People with preexisting diabetes or gestational diabetes need to have a choice in what therapy they use for their diabetes and blood sugar management during a very vulnerable time in their lives. The decision to stop production of Levemir insulin has taken away a proven effective and safe insulin during pregnancy and should be reconsidered to allow patients and their providers to continue to provide the best care possible during pregnancy. Catherine Sullivan, MD

I am a Maternal Fetal Medicine physician for 40 years. Helping women with diabetes have a healthy pregnancy in the past decade has been made possible through the efforts of medications such as Levemir. Maintaining a healthy glucose/sugar level has been made possible through the use of medications such as Levemir. Keeping sugar levels in pregnancy in the normal range has not only short term benefits for the mothers but also has long term benefits for the offspring. If you are interested in not only short term treatments but long term prevention of health issues for the next generation, then please reconsider keeping Levemir available for pregnant women. Patrick Catalano, MD

Levemir is a critical therapeutic option for pregnant individuals, and it has been a trusted therapy for years. There are many women who cannot tolerate insulin glargine for a number of different reasons, and the loss of Levemir leaves us without a viable option. NPH has a defined peak, and we often encounter issues with overnight hyperglycemia when we try to treat the elevated fasting glucose values that are so common in pregnancy. Although there is limited data regarding degludec use in pregnancy, the available studies were not adequately powered to show differences in maternal and fetal outcomes. Thank you for your consideration. Cristina Scifres, MD

Pregnancy is a challenging life stage for people with diabetes because of the dynamic metabolic adaptation that occurs. Therefore, it is essential to have various options of insulin types available for use to not only adapt to the metabolic demands but also give pregnant individuals the autonomy (busy schedules, juggling family/work/life, and changes in sleep, unexpected pregnancy complications, etc) and confidence over their diabetes care. Levemir, particularly in the first trimester when there is increased sensitivity for people with T1D can be very useful to adjust the day and night dosing of their long-acting insulin. Many of our people with gestational diabetes have only fasting hyperglycemia so the option is excellent to use at bedtime to not affect their daytime risk for hypoglycemia. Amy M. Valent, D.O., M.C.R.

I am a board-certified endocrinologist with more than 20 years of practice experience. Levemir has a unique role for women who are dependent on insulin for diabetes in pregnancy. The other available basal insulins in the US have not been studied with the same rigor in pregnancy and have disadvantages due to long duration of action that could put pregnant women at risk because of the rapidly changing insulin needs in the various stages of pregnancy and post-partum. Please keep Levemir available in the US. Caroline Roberts, MD

The use of detemir in pregnancy is supported by a robust randomized controlled trial (RCT) of glycemic, pregnancy, and neonatal outcomes. It has proven safety and efficacy. Detemir is preferentially used in pregnancy by experts over other basal insulins. This preference is in part a function of detemir's pharmacokinetic characteristics, such as the relatively short half-life that allows for split dosing to help mitigate the morning glucose rise during pregnancy, and its faster metabolism which helps avoid hypoglycemia in the setting of a sudden reduction in insulin resistance post-partum. Other long-acting insulins have remaining questions about applicability of use in this population. A recent RCT of insulin degludec was not powered to detect a difference between treatments in the maternal safety and pregnancy outcomes and did not report on risk of post-partum hypoglycemia that would be expected with its long duration of action. Florence Brown, MD

Levemir provides a specific advantage over other basal insulin options in that it does not have a dramatic peak and trough effect and that its duration of action in the body in pregnancy approximates 12 hours. For pregnant women, this pharmacokinetic profile is particularly useful for addressing overnight and fasting hyperglycemia without increasing the risk of late morning and early afternoon hypoglycemia due to ongoing basal insulin effect. Victoria Sandler, MD

As a Certified Diabetes Care and Education Specialist who specializes in pregnancy, I am quite concerned about the discontinuation of Levemir. There are only two basal insulins that have been rigorously studied in pregnancy; Levemir and NPH. NPH is an outdated, inferior insulin which is quite problematic due to its strong peak, which frequently results in hypoglycemia. Long-acting insulin glargine (Lantus/Basaglar/Semglee) has not been studied in RCT's, and insulin degludec's (Tresiba) very long action, is problematic as insulin needs change rapidly during pregnancy. This could result in dangerous hypoglycemic episodes. A more flexible option is needed, which is insulin detemir (Levemir). Pregnant people who use insulin are being forced to either suboptimal control, or an insulin pump. Not all patients can afford an insulin pump. Prenatal outcomes will be negatively affected by this discontinuation. Allison Herschede, BSN, RN, CDCES

The discontinuation of Levemir comes at great cost to our pregnant patients. Levemir is the only long-acting insulin that has had randomized controlled trials conducted in pregnant women, and for some time has been recognized as the safest insulin option for pregnant patients. It is the only FDA approved basal insulin for pregnancy. Additionally, discontinuing Levemir without a biosimilar (detemir) leaves no option for patients who are intolerant to insulin glargine. We would ask that you reconsider discontinuation until another biosimilar is made available. We want to keep our most vulnerable populations safe, especially in the context of rising maternal and infant mortality in the US. Makala Smith MS, RDN, BC-ADM, CDCES

Levemir® is one of the most used formulations in pregnancy given its maternal and fetal safety profile. Data from clinical trials demonstrated lower rates of severe hypoglycemia with insulin Levemir® compared to NPH in pregnant individuals with type 1 diabetes. Levemir's pharmacologic properties makes it ideal to match the varying basal needs in pregnancy. The twice daily dosing allows for the flexibility to match the bifurcated insulin needs during pregnancy. Clinical trial findings supported the FDA's approval of Levemir® for a pregnancy Category B classification in 2012. I cannot stress enough how rare this categorization is for drugs used in pregnancy and the level of reassurance it provides for patients and providers.

The decision to stop producing insulin Levemir® will have a dire impact on the therapeutic landscape of diabetes in pregnancy. Non-insulin alternatives are standard outside of pregnancy. However, findings of transplacental transfer of glyburide and metformin as well as embryotoxic effects in animal models on newer agents have limited the use of non-insulin drugs in pregnancy. Pregnant individuals with diabetes are faced with significant potential maternal and risks as well as limited treatment options because of concerns for safety. Further limits on their treatment options because of global manufacturing issues and decreasing patient coverage will leave patients with fewer treatment options and no equivalent treatment options during pregnancy. Maisa Feghali, MD, MSCR

The loss of detemir from the therapeutic landscape has had a direct and significant impact on patient safety and on our ability to provide evidence-based, patient-centered care. In my practice, insulin detemir has remained indispensable in two critical clinical scenarios. First, for very young children--typically between ages 3 and 6--who are not yet developmentally ready for insulin pump therapy and require multiple daily injections, once-daily glargine often provides an excessively prolonged basal effect. Detemir's predictable pharmacokinetic and flexible 12-hour dosing allow us to tailor basal coverage safely and effectively for this vulnerable age group.

Second, adolescents who require temporary "pump holidays" due to device fatigue, psychosocial stressors, or logistical challenges benefit greatly from detemir. Their widely variable schedules, irregular sleep patterns, and increased hypoglycemia risk make once-daily long-acting analogs such as glargine or degludec less suitable.

Detemir provides a safer, more adaptable basal insulin profile for these real-world circumstances.

Based on these experiences, I can state unequivocally that continued access to insulin detemir remains essential for many pediatric patients. Kannan Kasturi, MD

I have had many patients for whom the most effective insulins is levemir. It was a shock when it was pretty suddenly no longer available. We have struggled to find a substitute that works half as well. Richard Sharp, MD

Dememir has been a mainstay for our clinic patients, many of whom are underserved. Please bring it back! Steve Scharmann, MD

Insulin with a variety of "length/duration of action" is important to fine tune the care of diabetics. Please allow the open market manufacture of Detemir. Michael Howsley, MD

As a physician, I think patients need options for insulin treatment including levemir. Mike Adams MD

To whom it may concern,

I am writing in support of maintaining availability of Levemir insulin. This is an important form of insulin for many diabetics. Thank you,Dr. Mark Milligan

I support production of Levemir. J. Crandal, MD

We need as many Insulin options as we can have. Please let them produce this product. Charles Beau, MD

Backup options for my campers (at diabetes camp in the summer) including staff/adults, is very important for safety! Pump sites fail, their insulin degrades, we need ALL the options so kids and families can do all the activities of life without fear! Suzanne Lee, MD

To Whom it May Concern,

Diabetes is a growing challenge, not decreasing. Please allow us the full cohort of tools possible to help our patients. Especially in pregnancy. I respectfully request your help in this concerning matter. Sincerely, L. Wilson, MD H Kapanka, MD People need choice! Ogden, UT

Hello! I am a Podiatrist who works with many patients who have diabetes and neuropathy. Limb salvage is an important part of my practice. Good blood glucose control is extremely important in preserving nerve, kidney, eye and cardiovascular function. Insulin Detemir can help with brittle diabetes control, and in my opinion it is medically necessary. Also, after amputation, life expectancy is often decreased. In addition, neuropathy also effects our other nervous system, the autonomic nerve system. This system controls heart, gastro intestinal and sexual function. Lastly, this type of insulin will greatly help those in 3rd world countries, where insulin pumps are not available. PLEASE KEEP INSULIN DETEMIR AVAILABLE. C. McManama, DPM

As a family practice physician, patients need choice and not everyone tolerates the same treatment. There's no alternative for detemir. Please help us keep options available. Layne Kamalu, MD

I am a pediatric endocrinologist and I regularly use Levemir in my practice for newly diagnosed children with diabetes in which other forms of insulin are long acting and dangerous (insulin glargine) or technology heavy (insulin pumps). I also use them for adolescents wanting a pump break in whom fixed sleep/wake cycles are difficult to expect. Detemir has been life saving in these patient groups. Kannan Kasturi

I am in favor of providing access and production coverage for this insulin drug Levemir. Douglas K Anderson, MD

To whom it may concern, I am a physician anesthesiologist in UT, USA. I am concerned by the history of and trend of limiting the manufacturing and sale of insulin. Patients and physicians need many options for insulin medications. Scott Bunker, DO

More choices is always better than fewer. Individualized care is critical in medicine. There are certain patients who stand to benefit from Levemir insulin. I ask that everything can be done to bring back Levemir to the market. Marc Johnson, MD

As a pediatric endocrinologist who had prescribed Levemir for hundreds of patients, I strongly support the continued availability of this specific insulin. Thank you very much for considering this request. Paul Pelavin, MSc, MD

I am a pediatric endocrinologist who would like to support detemir production as it gives opportunity for increased choice in diabetes management. Allison Smego

Insulin Detemir (Levemir) should be a drug in shortage. There is no other similar drug on the market. It has a unique profile that is essential for many diabetics including pregnant women. I am in support of the ability for other manufacturers to be able to make this fantastic drug. Please allow this to happen. Lives will be saved! Allen Francis, MD Granite Wellness Center, Medical Director

Who makes these decisions? Must not be anyone with training or education. I treat diabetic foot wounds. I guess I can thank you for increasing my business (Sarcasm)! Let’s cut off more lets! Please reconsider your decision. Riley Rampton, DPM

Individuals with diabetes who are pregnant need access to safe and effective insulins with proven benefit in this population. Insulin detemir should be available to these individuals and studies need to be completed to show whether other insulins are safe in this population. Alissa R. Segal, PharmD MDPHS University, Editor in Chief of ADA Journal Diabetes, Obesity and CardioMetabolic CARE

To whom it may concern,

Although I do not routinely prescribe insulin detemir (Levemir), I STRONGLY SUPPORT maintaining access to multiple basal insulin options. In clinical medicine, patients respond differently to various insulin formulation, and preserving, therapeutic, flexibility, is important for individualized, patient centered care. Even clinicians who use insulin infrequently recognize the value of maintaining access to established medications that have demonstrated safely, reliability, and unique pharmacological characteristics over many years of use. Sincerely, Kirsten Baca, MD

It's unfortunate about Levemir not being available because I have many patients who relied on it for control over a 24 hour period. They are very upset. Glargine has too many peaks and valleys. Many are athletes and appreciate the ability to exercise and not get low. I'm an endocrinologist at UCSD in San Diego. Steven V. Edelman, MD

My name is Ray Ward. I am a practicing family physician, and I serve in the Utah House of Representatives - House district 19, serving Bountiful and West Bountiful. I used to write some prescriptions for Insulin glargine and some for insulin detemir. Now the patients that used to do well with detemir have all been forced to switch to glargine. Last Year I had an older patient whose has a hard time remembering and following instructions.

She overdosed on her insulin glargine and was admitted to the hospital ina coma because of life threatening hypoglycemia. She was in the ICU for 3 whole days on a glucose drip because thats how long it took for the glargine to clear from her system. If she had been on detemir, it would have cleared from her system in 1 day. After she came out of the hospital - it would have been great to switch her to the detemir, in case it happened again, but that option has been taken away.

Please declare the drug in shortage so we can get back to having a manufacture who will be willing to produce detemir again. Some patients clearly do better with this version of insulin. Some prescribers (like me) clearly want to have the option available sometimes (like during pregnancy or when the very long effect of insulin glargine has injured a patient). The medicine has a long and good track record. The only reason we have lost it is that Novo Nordisk has other insulin products that make it a higher profit margin, and the FDAs normal process is so expensive that manufacturers understand that they can't get through it in a way that keeps them in business.

The drug is clearly in shortage since it isn't being produced at all. The mission of the FDA is to make sure that safe medications are readily available to patients who need them. I ask that the FDA will please designate insulin detemir as being in shortage so that we can have a chance for this medicine to continue to exist. Ray Ward, MD

Please allow variety in the production of Insulin. John Sanders, DO, Family Physician

Detemir is an insulin product that is necessary for many patients & provides a unique duration of action that can help patients who are unable to use the longer acting basal insulins. Having hypoglycemia with a longer duration basal insulin allows detemir to fill this void. Sarah Iannacone, PharmD, Ogden, UT

Levemir is great for pregnancy. Dr.V. Mohan

I have multiple patients that still need Levemir. Please continue to supply this insulin! Dr. Pettus, endocrinologist, UC San Diego

As a Family Medicine/Sports Medicine physican since 1984, I strongly advocate for keeping insulin Detemir (Levemir) available as an option for both Type 2, but ESPECIALLY Type 1 diabetics. It is uniquely flexible as a basal type of insulin.

I also am a type 1 diabetic since 1968, served as a diabetic camp physician for 20 years. Insulin detemir is especially helpful for female diabetics, in order to adjust basal insulin needs at phases of the menstrual cycle. David K. Tensmeyer, MD

Many of my patients need a choice in insulin especially meds like levemir. Please make this happen Robert Alley, MD

I am a pediatric endocrinologist . I strongly support efforts to preserve access to insulin detemir or to facilitate development of a biosimilar alternative. The concerns outlined in this petition are clinically meaningful and reflect real challenges we are already encountering in practice.

In pediatric diabetes care, insulin flexibility matters greatly. Many children, adolescents, athletes, pregnant individuals, and patients with highly variable insulin sensitivity benefit from the shorter and more adjustable action profile of detemir compared with other currently available basal insulins. For some patients, transitioning to glargine or degludec has resulted in increased glycemic variability, hypoglycemia, hyperglycemia, or reduced quality of life.

Detemir has also been especially important in very young children and newly diagnosed patients requiring extremely small insulin doses. The loss of this option disproportionately affects vulnerable pediatric populations.

While many patients can transition successfully to alternative basal insulins, others cannot achieve the same degree of glucose stability, flexibility, or safety. Preserving therapeutic choice in insulin management is important because diabetes care is highly individualized, and patients respond differently to available basal insulin formulations.

I support the advocacy for exploring regulatory pathways that would preserve access to detemir, including facilitating biosimilar development, accelerating review pathways, and working collaboratively with manufacturers to minimize disruption in patient care. Vandana Raman

I am a pharmacist and understand the importance of Levemir. We either need to bring Levemir (insulin detemir) back to the market or allocate funding to study insulin use (insulin degludec/glargine) in pregnancy. Christy Schumacher, Pharm D. Professor, Midwestern University, Pharmacist, Northwestern Medicine

As a wound care/hyperbaric medicine physician with a limb preservation focus, Limiting our insulin options increases poor outcomes in our Diabetic Population. Please consider allowing the return of Levemir to our pharmaceutical Market. Our diabetes will thank you. Please reach out to discuss. Jeremy Kessler

To FDA Commission: PLEASE PLEASE support choice among insulin options! I am a 30 yr fam doc and father of two type 1 DM. My children and my patients have struggled being faced to go from one insulin to another based on their insurance (or lack thereof) or their employer. There is not a one-size-fits-all when it comes to Insulin and management of type 1 DM. Sincerely, Michael L. Rhodes, MD

I am a physician in Australia, and am concerned that the loss of Levemir insulin from the market will leave some patients without the insulin that best suits their needs. Jonathan Shaw, FRACP

Please help us keep insulin options open for all of our unique patient with unique needs. S Kirby, MD

Please, reinstate and continue manufacturing detemir for my family member to have better insulin delivery. Cheryl Walczak, MD

Detemir should remain available as a tx option because many patience have been stable and well controlled on it. It has been a cost effective insulin for many individuals, and switching to another basal insulin creates challenges with dose adjustment, glucose control, hypoglycemia risk, side affects, and increased costs. Diabetes treatments should remain individualized and patients doing well on detemir should continue to have access to it. Thank you Natividad a Rodruigez, MD

We need more diabetic treatments options especially less expensive ones. Approve Levemir options! Johnnie Cook MD

As a father of a daughter with Type I Diabetes, I feel it is important to have choices of Insulin including Levemir. Curtis Campbell, MD

Individuals with diabetes who are pregnant need access to safe and effective insulins with proven benefit in this population. Insulin detemir should be available to these individuals and studies need to be completed to show whether other insulins are safe in this population. Alissa R. Segal, PharmD MDPHS University, Editor in Chief of ADA Journal Diabetes, Obesity and CardioMetabolic CARE

Insulin is necessary and life saving for patients with T1D. It is so important that there are affordable options for patients to use to fil their specific needs. We need more Levemir! Savanna Cox, MD

Levemir, or insulin detemir, is an important medication in many patients' diabetes management plans, particularly pregnant women.

Other long-acting agents are not necessarily safe or appropriate for those patients, and the care gap created by the unavailability of detemir has and will cause patients harm. W. Kyle Christensen, DO

Please consider bringing Levemir back to market - patients and providers would really benefit from having Levemir back for pregnancy. Anders Carlson, MD

I support the continued use and manufacturing of Levemir. Brian Heaton, MD

I have just been made aware of the loss of insulin detemir from national production/formularies. Because of its unique properties, such as shorter duration, steady absorption, and as backup for pump malfunctions, insulin detemir must continue to be available for those patients who rely on it. Please find a way to make this happen! Douglas Reinhardt, MD

Financial gain from patented medications should never trump patient safety. Pharmaceuticals are available to serve patients, not as a means of extortion. Ben Barraclough, DO

We need Levemir! Especially for our complex kids on tube feeds! Natalie Segev, MD

As a Family medicine physician I have numerous patients w/ diabetes that are on insulin. As with all treatment options, there are different medications that work for some of my patients that do not work for others. Because of this, it is important that we have the most safe options available to patients as possible. If possible, we should keep all the various insulin options available to our diabetics. Sam Johnson, MD

Please support production of levemir. Bryan Campbell, MD

We need Levemir urgently! Physician primary care, Franz Rinninger, MD

I am a Pediatric Endocrinology Fellow PGY-5

Patient choice and individualized care are essential for optimal management of type 1 diabetes. Levemir is the only basal insulin analogue that has randomized controlled trial data supporting its safety and efficacy in pregnant women with type 1 diabetes, with this distinction recognized by the ADA Standards of Care. While observational data exists with other basal insulin analogues, there are additional challenges that may exist (such as the prolonged duration of action of insulin degludec with long half-life leading to inadequate ability to rapidly titrate insulin to meet the demands of changes experiences during pregnancy) that is explicitly described in the ADA Standards of Care. I support the movement to prioritize and maintain patient choice, especially when it comes to the insulin choice for optimal management of type 1 diabetes. Sydney Look, Pediatric Endocrinology Fellow PGY-5, The University of Utah Department of Pediatrics

Hello,

I am a maternal-fetal medicine subspecialist and director of our diabetes and pregnancy program. I care for pregnant people with type 1, type 2, gestational, pancreatic insufficiency, and genetic forms of diabetes. The management of all of these forms of diabetes have the goal of optimizing sugars to be within a pregnancy target range (63-140mg/dL), which is much lower than the non-pregnant range.

Often, to achieve our goals, patients require insulin. Our body's natural insulin secretion is very complex, responding to stress, food, rest, exercise, etc. Therefore, having insulin with different pharmacokinetics and pharmacodynamics is imperative to be able to individualize treatment to achieve our goals.

Moreover, pregnancy is a dynamic state of change - physically, hormonally, anatomically, and metabolically. I see each patient weekly to review blood or CGM glucose and make medication changes to keep up (stay ahead) of the pregnancy changes to reduce the complications associated with elevated blood sugars for the pregnancy and the offspring. The current long acting insulins available are challenging to titrate due to the long duration (degludec) or shorter than a day (therefore requiring twice a day dosing but risk insulin overlap and hypoglycemia; glargine) or intermediate and peak (NPH) which can significantly risk patients to experience hyperglycemia and hypoglycemia due to challenges in being able to time insulins well, titrate to cover hyperglycemia but avoid later hypoglycemia, or the rapid changes in pregnancy make it difficult to titrate insulin dosing.

Levemir/detemir was very useful in pregnancy because of the relatively flat insulin profile but the overall duration was convenient to be able to dose twice a day. Particularly our patients with type 1 diabetes have increased vulnerability of hypoglycemia at night but require more insulin during the day so having the ability to have different doses in the overnight and day time was extremely convenient.

Even in the era of having AID systems, it is often challenging to get covered for our patients, primarily only type 1 diabetes and not all individuals even with type 1 diabetes are good candidates for pump therapy (adhesive issues, connection issues, unable to manage pump therapy, etc). Having more options of insulin formulations can improve our ability as providers to tailor care and help patients achieve pregnancy glucose goals.

I have had patients unnecessarily experience severe hypoglycemia, yo yo-ing glucose (significant variability) which is not safe for the patient or her baby, or unable to treat their hyperglycemia adequately or consistently. I had a patient recently with type 2 diabetes who had hyperglycemia majority of the evening but when increasing her glargine would have hypoglycemia in the late morning because of her schedule and inability to eat until mid morning.

I was unable to twice a day dose her glargine because it would make her coming crashing hypoglycemia even more. She was too scared to give herself rapid acting insulin to correct her sugars and NPH was not working for her because she was unable to time it consistently every day and would end up getting hypoglycemic overnight as well. Levemir would have been excellent for this patient to be able to have a shorter long-acting insulin to be able to dose her differently in the day and night.

My colleagues who are not as familiar with the different insulins are unable to troubleshoot through all of these cases. The volume of diabetes is increasing annually, particularly type 2 and GDM. We need more help as physicians to have different insulin options. Having the menu of insulins to be able to work with patients and make them feel confident and safe with their treatment is critical for their success in their pregnancy and improving outcomes.

The psychological stress of diabetes in pregnancy is already challenging and worrying about their sugars should not be another hurdle. please allow us as physicians to have options and flexibility in insulin choices. Please bring back levemir so we have another safe option to work with. We don't have other options that are effective or as safe as insulin in pregnancy. Amy Valent

I’m a physician who has managed type 1 diabetic children in camp. We need Levemir option for intermediate acting insulin. Please designate as “drug in shortage.” Ed Sarver, MD

As an emergency medicine physician I strongly feel that detemir should remain available in order to optimally control blood glucose. Bennion D. Buchanan, MD, MBA FACEP

Levemir is a good prodeuct that helps diabetic patients. I would support efforts to get this manufactured for these purposes. Scott Peterson, MD

I am a Pediatric Endocrinologist and I take care of about 300 children with type 1 diabetes. Insulin detemir is not used frequently, but it is important for patients to have a choice when it comes to the various insulin options. If NovoNordisk will not continue to manufacture insulin detemir, then it is reasonable to request that the organization sign over the rights so another company could manufacture it. Scott Clements

Levemir is a good prodeuct that helps diabetic patients. I would support efforts to get this manufactured for these purposes. Scott Peterson, MD

Please continue availability of insulin detemir and include it in medication shortage protection planning. Levemir provides a more stable and predictable basal insulin action for many Type 1 diabetes pts compared with some remaining ultra-long acting insulins.

Type 1 diabetics are fully insulin dependent and less responsive to lifestyle modifications than many type 2 diabetes pts. Because of this, changes to basal insulin can place them at increased risk of severe hypoglycemia, diabetic ketoacidosis, neurologic injury, hospitalization, and other serious complications.

Levemir remains an important and safer treatment option for some type 1 pts due to its pharmacokinetic profile and dosing flexibility. Randall Steinfeldt, MD

I am an internist who has used insulin extensively. There are patients for whom detemir insulin works very well and change to another insulin would be difficult and not likely to be optimal treatment. Paul Lehmitz, MD

To whom it may concern, I am a family physician and have practiced for 28 years in Ogden, UT. I have learned that a particular basal insulin could become available if certain pathways are impacted. I have prescribed Levemir successfully for many years. Please consider carefully what needs to be done to make this flexible and effective basal insulin available. Sincerely, Kurt Rifleman, MD

Patients do better with different types of insulin - for each patient is unique! Wendell Nilson, MD , St George Pediatrician

I’m a physician who has managed type 1 diabetic children in camp. We need Levemir option for intermediate acting insulin. Please designate as “drug in shortage.” Ed Sarver, MD

To Whom it may concern-Regarding insulin availability, particularly shorter acting insulin. I have a son with type 1 diabetes who uses a pump often. But there are times when a short term injectable insulin is more advantageous. Short term (fast acting) insulin is becoming less available, and generally insulin is still unrealistic expensive even though it has even around for decades. We need more availability and better pricing- thank you, Val B. Johnson, MD

I have a newly diagnosed 2-year-old patient who is using Levemir once daily. he is very sensitive to insulin, so this is the best option for a long-acting insulin for him. His parents and I would very much appreciate the continued ability to be able to access and use Levemir. Emily King, MD

My name is Erin Cleary; I am a maternal-fetal medicine physician and assistant professor of OBGYN at Indiana University

I assume the management of diabetes during pregnancy for many people with pre-gestational diabetes. Detemir has a reassuring safety profile in pregnancy, allowing us to safely continue and adjust dosing in pregnancy or initiate it in pregnancy.

Without Detemir, patients have fewer options for long-acting insulin, and for those with allergy or an intolerance to alternatives, their care suffers and they are subject to increased risk to adverse outcomes. Erin Cleary

This is Dr Critt Aardema,

Writing this to encourage the continuous production and availability of Levemir. Dr Critt Aardema

Levemir is essential for caring for diabetes patients - especially those who are pregnant as it is one of the only insulins that has excellent RCR data Emily Rosenberg, MD

I am a physician practicing in Dallas, Texas who treats pregnant patients with diabetes. Insulin Levemir helped many of my patients and I consider it the best choice for intermediate/long-acting basal insulin in pregnancy. Maria Ramos, MD

As an impatient hospital provider, I am often consulted on peri-operative pts, with glucose instability. They often have hyperglycemia post-op due to routine use of steroids in the OR. This is predictable in the short term though requires a lot of lisprlitumalog to control. Long-acting agents are difficult to dose with short-term needs, please keep intermediate-acting insulins available. Charlene Ollerton, FNP Hospitalist, 4401 Harrison Blvd. Ogden, UT 84403

We need to have ongoing access to all different formulations of insulin as patient needs vary. Focus should be on community health and not improving revenue. Nate Gracey, SA-C , Internal Medicine

Levemir is a great product for pregnancy -Professor Ponnusamy Saravanan

I would strongly encourage that Levemir be returned for use among diabetic patients. It is a safer option and life saving in many situations. What has happened is criminal. Have been in medicine for over 30 years! Kimberly Allen, ACNP-BC

Dear Sir/Ma"am,

Please allow a path for Levemir/detemir to be made available to those who need it. There is NO alternative. Thank you. Dallen J. Larson, PA-C

Please help us ensure we have a variety of options to care for our diabetic patients. Insulin is NOT an optional medication for those who need it. We need to have options for patients who are sensitive to other insulins, who are pregnant, or those with fluctuating basal insulin levels. Patients need to have options and alternatives. Please help us! Christopher Beers DNP

Please help us keep all forms of insulin available and accessible for all patients. There are many needs and this can be life-threatening to many if not accessible. Carrie Bryant, PA-C

As a wound care and hyperbaric trained APRN I treat many diabetic patients. Many of my patients are poorly controlled. Patients in my practice often live with a fixed income and have difficulty obtaining their insulin. My patients would benefit from additional affordable insulin choices. Jason Eaton, FNP-C, CAE-HAP

Short acting insulin like detemir is such an important choice for our patients—better glucose control and less hypoglycemic issues—please do not discontinue Levemir. Paul McOmber PA-C

I, Karyn Anne Hardy, Family Nurse Practitioner of 26 years and RN for 31 years support the use of Levemir for pediatrics, adults, and during pregnancy. This drug is essential. Thanks. Karyn Anne Hardy

Please allow generic production of Levemir Insulin as soon as possible for patient treatment benefit. Thanks! Gary Heaston PAC Brigham City, Utah

Greetings,

I worry what will happen when Detemir is discontinued? There is no other Insulin type to replace it. Everything else lasts a lot longer and can be very unsafe for people--especially children, teens and pregnant women. PLEASE we need this Insulin! Cindy Haadcke, FNP-C

As an RN CDCES who works with pregnant patients with diabetes and with pediatric patients, I can say that many are struggling due to the loss of Detemir. The currently available long-acting insulins are not flexible enough for people with rapidly changing insulin needs, which leads to hypo and hyperglycemic excursions and suboptimal glucose control when it is needed the most. Allison Herschede

Patients need a variety of options for their care. To provide better care for a variety of patients we need more choices to better fit them. One drug may work better than others for one individual. Health care is not a one size fits all. Mikaydee Rich, BSN, RN

Levemir is a crucial long-lasting insulin with a duration that offers much better control and is a safer option for many people. Without this, people could be harmed. It is vital for pregnant women, athletes, and youth who need accurate and flexible control. More options can also help keep prices down.

It is essential that Levemir is available for those who depend on it/require it and options are a necessity for optimal therapeutic outcomes. Thank you, Kara Higginson, RN

Insulin should not be a "one size fits all" state of mind. I have had the opportunity to help many patients that depend on insulin and have seen the many adjustments needed because every patients needs are unique. Please do not remove any insulin options that could save lives! Shawnny, RN

Please help keep diabetic treatment options open. Our patients need viable options. Levemir is helpful to continued overall help to keep our patients healthy especially in my wound care patients. Madison Foster

To whom it may concern,

Diabetes runs in my family and its important to me to have affordable options. Please give Levemir a chance for a patient. Christina T, wound care tech

Patients need more options and cost effective medications. Medications are not a one size fits all. Mindee Manning, wound care tech

I work in healthcare. I believe that choices for insulin is imperative. I have worked with diabetics and it is needed to have other options especially for prenatal mothers. Leesa Gammell, hyperbaric tech

We need more options for affordable insulin. Please give Levemir the chance to remain an option for patients. Mary Christensen , Office Manager , Bridge Point Wound Care & Hyperbaric

Novo Nordisk is the largest company in Europe and produces 50% of the world's insulin. In March of 2023, Novo Nordisk announced that it would lower the USA price of its basal (long-acting) insulin Levemir by 65%. In November of 2023 (8 months later), Novo Nordisk announced that it would discontinue Levemir in the USA by December 2024, and has done so.

There are precious few basal insulin choices:

• Glargine(Lantus/Sanofi, Basaglar/Eli Lilly, Semglee/Mylan Pharmaceuticals)

• Detemir(Levemir/Novo Nordisk)

• Degludec(Tresiba/Novo Nordisk)

Despite propoganda from Novo Nordisk, those basal insulins are quite different from each other:

• Glargine:24-hour half-life

• Detemir:7-hour half-life

• Degludec:25-hour half-life

Growing children, with different AM/PM basal needs from the overnight release of growth hormone, athletes, and pregnant women all critically need Levemir. Additionally, Levemir is the only basal insulin that can be diluted, critically important for infants, toddlers, and for many newly diagnosed persons that require only very small doses of insulin. I know all of this firsthand because my now 20 year old son was diagnosed with type 1 diabetes in 2010, at the age of 5.

Most Levemir users are now being forced to insulin glargine (Lantus or a biosimilar) due to the many glargine biosimilar options and their impact on lowering prices. However, glargine insulins carry an extreme danger (commonly known as “Lantus Lows”) from how glargine depends on a pH shift to form micro-precipitates when injected. If a glargine injection hits a vein or capillary instead of subcutaneous fatty tissue, that injection can impact the body as a rapid acting insulin would (immediately) instead of the slow-action (24-hour half-life) that is intended. Despite the industry narrative, this phenomenon snot conjecture.

Page 45 of the official Lantus product monograph (https://pdf.hres.ca/dpd_pm/00041813.PDF) reads as follows: “Hypoglycemia can result from injection directly into a blood vessel and if not recognized or treated may be followed by hyperglycemia since there was no LANTUS deposition for long-term absorption.” Artificial intelligence systems such as Google Gemini fully understand the danger, as shown in the attached document.

Losing Levemir is devastating and it should be reversed by regulators until Novo Nordisk licenses Levemir to another manufacturer or a biosimilar replacement comes to market. Importantly, if Novo Nordisk is allowed to remove Levemir from the US market now, no other company could ever produce a biosimilar of it here because the FDA requires that head to head studies be performed with the product supplied in the USA. Even if the exact product is available in other countries, it does not matter. Moreover, Novo Nordisk has made a series of announcements about the discontinuation of Levemir in many countries around the world, to occur in 2025 and 2026.

Novo Nordisk should not be allowed to discontinue this product simply to shift production capacity to its now much more profitable, blockbuster GPL-1 drugs, without first ensuring that this vital hormone is otherwise available to people with diabetes who need it. Detemir is on the World Health Organization’s list of essential medicines. I request that the FDA declare detemir to be a drug in shortage and to act quickly to allow other companies to manufacture it, in the short term, and to support longer-term access through regulatory flexibility in a biosimilar approval pathway. Sincerely, Lester Hightower, Orange Park, Florida 32073

We request:

• Detemir insulin to be on the FDA Drug Shortage List

• A 503B-registered outsourcing facility to be able to manufacture detemir while it remains on the shortage list. Alliance to Protect Insulin Choice

Free Levemir! -Scott Banner, Juicebox Podcast

Please bring back the long acting insulin that can be used in pregnancy. Evelyn Geilmann

My son, age 11, was diagnosed type 1 diabetic at age 2. He has been using Levemir for many years and it would be an extreme hardship if he could no longer use it, as alternatives such as Tresiba (causes bloody noses and is too long acting) and Lantus (causes frightening and deadly lows) are not fit for him. He has used a pump in the past and if he could not get Levemir, he could go back to it, but at only age 11 his body still does not have adequate mass to comfortably wear a pump and his Dexcom continuous glucose monitor at the same time, and changing the pump every few days wore him down quite rapidly. He does quite well with Levemir (detemir), and we are asking that it be cleared for manufacturing. Matthew Kneeland

My teen daughter’s insulin needs slowly rise and fall over the course of a single month. She can adjust her dose of Levemir to match those changes. This flexibility allows her to maintain well controlled blood glucose with minimal time spent with hypo- and hyperglycemia, so she can feel well and remain safe.

She is able to compete safely as an athlete with Levemir. For the past several years using Levemir, she has not had any significant disruption to her athletic pursuits. After a full day of tournament play she can decrease her dose to reduce the risk of overnight hypoglycemia.

She tried glargine for multiple months on two separate occasions. It felt “sticky,” and harder to quickly see the change in the amount of insulin given to match the need to help her keep the good blood glucose control she is accustomed to. This would make Tresiba an even more unsuitable option because of its ultra long profile.

In addition to glargine’s duration being longer than detemir, we have serious concerns about unpredictable hypoglycemia if glargine is injected into a blood vessel.

Detemir is essential for healthy pregnancies. With the drastic change in insulin needs over the course of a pregnancy, culminating in the typically abrupt decrease in insulin needed after delivery, detemir is essential to manage the tight blood sugar control needed for a healthy pregnancy outcome.

My daughter used an insulin pump for several months. During that time, she repeatedly had to removed the pump and administer insulin by injection during competitive athletic activity due to significantly wider and unsafe blood glucose swings. This occurred during intense exertion. In contrast, she is able to manage her glucose levels safely and effectively with detemir.

This is not just a matter of preference, it is a clear patient safety issue, as there is no therapeutic alternative, and its discontinuation will directly lead to patient harm. Alison Smart

Levemir Insulin. I have used levemir insulin for 15+ years. I mainly use it now when I need to take a break from my insulin pump. I only use it 4-7 days before going back on the pump. I need to use a long acting insulin if I’m not wearing the pump 24/7. Levemir insulin is the ONLY long acting insulin that you can use this way. The other long acting insulin’s out there such as lantus and others usually take 3-5 days for your body to adjust to.

And because I only use it for a week at a time or less this is not feasible to use the others. I am in the 300/400’s when I use the others until it decides to get acclimated to my body. I’ve had type 1 since the early 1980’s so I already have permanent/severe complications from having it for so long and not having the access of better insulins, insulin pumps, CGMs, or better knowledge.

If levemir insulin is taken away with no replacement it will be like going back in the dark ages of the 1970’s/1980’s where people won’t have access to the medications they need. The other insulin may keep us alive, but the ones that rely on levemir will not have a great quality of life. Not to mention it will definitely cost more in the long run with hospitalizations and procedures from erratic blood sugars and treatment of complications. Thank you for your consideration. Betsy S

Levemir has been the only long-acting insulin that has allowed me to manage my blood sugars to an A1c of 5.7% without significant hypoglycemia. I’ve lived with Type 1 diabetes since 1997 and have tried several long-acting insulins, including newer longer-lasting long-acting insulins. None of them has provided the same level of glucose stability.

My endocrinologist agrees that Levemir is the best option for me and the one that will allow me to continually stay free of diabetes complications. Not everyone living with diabetes is the same, we need access to the options that are best for the individual. Please make Levemir an option again. Christel Oerum

Levemir is an ideal insulin choice for many diabetics. My teenage daughter is an high level athlete and has unique insulin needs to control her type 1 diabetes. Levemir is ideal for athletes to help control and maintain their glucose levels while working out and competing. It is also crucial for everyday use. The discontinuation of Levemir is disheartening and very unfortunate. Everyone should have access to this essential life saving medication. Sarah Newman

Please help keep diabetic treatment options open. Levemir is helpful to continued overall help to keep our patients healthy. Levemir provides greater flexibility for blood glucose control for those in need. Robert Darby, OMS-III

As a worker with people with diabetes, PLEASE let there be many different kinds of insulin. Some patients can only do certain kinds. This unique insulin is prevalent in helping our patients. Bad decisions lead to limb loss. Please continue Levemir insulin. Continued access is so important. Anonymous

I am a Type 1 diabetic who has used the insulin Levemir (Detemir) for years. It works well for me. With the discontinuation of this insulin by NovoNordisk I am forced to take either Lantus or Tresiba. Neither works well for me. Lantus can give you instant and dangerous low blood sugar, which can be deadly. Tresiba is too long acting. It doesn’t allow for dosing flexibility and adjustments based on changes in diet, exercise, hormones, stress — and so many other factors.

I implore you to have NovoNordisk share the production methods of Levemir with another manufacturer so that the specific insulin that keeps me alive and keeps my blood sugar in fabulous control remains available to me and countless others who need it. People over profits. Stacey Silverman

Levemir is the foundational and critical insulin we use to keep my teenage son safe during these years when hormones cause insulin needs to change constantly. We can no longer find it in any pharmacy. We are going through our supply without being able to replenish it and there are no options currently on the market with a similar action profile. Patricia Johnson

Please designate Levemir as a drug in shortage. My 4 year old son uses Detemir (Levemir) because it is the basal insulin best suited to his rapidly changing insulin needs. We can adjust the dosage very quickly since it does not stay in his system as long as the other basal insulins. We just started using an insulin pump with him, and Detemir is the best basal for times when he is off the pump just briefly due to a middle of the night pump failure. Small children like him really benefit from this unique type of basal insulin. It is also the ideal basal insulin for many pregnant women and athletes. Anita San Juan

Levemir would be the ideal choice for both myself and my daughter. Allowing for basal adjustments that are responsive to needed adjustments daily, and avoiding the problems of infusion sets or NPH. Eitan Rosa

The basal insulin Levemir which was produced by Novo Nordisk is a unique form of insulin which has been invaluable to me as an insulin sensitive T1 diabetic currently navigating perimenopause. This means my insulin requirements vary with unpredictable hormonal shifts and dosing effects can have unpredictable and dangerous effects. The relatively short action time of Levemir as compared to other brands such as Lantus is essential to me, meaning that I can titrate my insulin intake three times a day. The 24 hour profile of lantus is shown to lead to significant hypos for me at its peak. I cannot control these as I cannot control the action time. Anonymous

My child is dependent on the insulin Levemir. We have a few months worth left from stocking up after hearing it was going to be discontinued. Like many parents realize early on, Levemir is a flexible insulin. You are able to change dosing strategies quickly and see the results of that the same day.

A child’s insulin needs tend to be the most unpredictable with growth spirts, food, exercise, hormonal changes, sickness, etc. Levemir has proven to be the safest, most effective insulin to manage my child’s diabetes and reach goals of non-diabetic blood sugars. Stef Malama

Levemir is the only long acting insulin that makes me feel well and doesn’t cause body changes and health risks . After Levemir being discontinued I was put on Lantus and Tresiba in a few months against my will but I had no choice . Both caused drastic weight gain even with me being very active and eating balanced meals . Made me feel out of breath even going up the stairs and I’m a fit person overall .

Libido was gone , loss of energy and instead feeling depressed . After getting access to Levemir leftovers , even with expired date , I still took a risk and in less then a month , I started feeling much better , lost extra LBs gained on Tresiba and Lantus and feeling like a human again ! Working and enjoying daily activities . Levemir or generic must be available in US just like it is around the world! Hanna Zalanskas

Insulin is not a one size fits all commodity. When access is restricted it affects patient needs and quality of life--please maintain our right to choose! Anonymous

My name is Bryon Veal. United Health Care is no longer allowing me to purchase Humalog, a rapid acting short term insulin that matched my body's slow digestion. They are now forcing me to purchase Novalog, since they took Humalog off of their formulary. Basically treating Humalog, a popular common insulin, as if it does not exist. As a type one diabetic for 50 years and 2 months, my digestion is slowed by diabetic complications.

The Novalog which I am now forced to purchase, works too quickly dropping my blood sugar to potentially dangerous low blood sugar. Then, because Novalog leaves the system quickly, my meal then spikes my blood sugar. Humalog matches my body rhythm perfectly. It doesnt peak too soon dropping my blood sugar, and stays in my system long enough to cover meals.

Please consider my situation, which is documented using an Eversense Constant Glucose Monitor. It clearly shows the safe blood sugar pattern using Humalog, and the dangerous blood sugar pattern, using Novalog. We need insulin catered to our body rhythm, not the insurance company's bottomline. As a type one diabetic with multiple hospitalizations, I have almost been killed by staff using wrong insulins they use, vs those I can supply matched to my body that keep me safe. Bryon Veal

I have been an insulin dependent diabetic for over 40 years. Because my insulin requirements are such that I need significantly different amounts during the day and night (between 2:1 and 3:1) any basal insulin that has a consistent action profile over 24 hrs is of no use to me. I have tried using a pump but it didn't work for me as I reacted to the pump canulas. I also cannot afford pumping as I am not covered under insurance. I manage my diabetes well but struggle balancing daytime against night time. Halvdan Wettre

I need Levemir (detemir). This insulin has helped me achieve non-diabetic A1C levels and allows me the ability to modify dosing on a daily basis. My dosing needs change depending on my activity level, stress level, even the outside temperature. No other basal allows this flexibility.

I used plants previously and it caused random lows to occcur. One of which happened while I was pregnant and driving home. I ended up blacking out. Levemir has never caused an issue like that. My endocrinologist has told me she won’t prescribe tresiba to me since the action period is too long and would cause me harm. Kathy Robertson

My son was diagnosed at age three, and he is now fifteen. We used Lantus in those early years. However, I was afraid of Lantus lows and we weren’t getting the results we wanted. We switched to Tresiba. But my son had SO MANY bloody noses. It was also hard to make quick adjustments. When puberty hit it became even more difficult, because Tresiba is so long acting.

Thankfully, we found Levemir and it has been so much better. Just this week we had to increase the amount he takes. We know that we can change the amount easily and see results quicker. We have tried our best to stock up on Levemir, but we are worried about the discontinuation. If we run out before there's a solution, we will be forced to go back to Tresiba. Heather Rigney

My name is Michela, and I have been living with type 1 diabetes since the age of 33.

I was initially prescribed Lantus, but I experienced a severe hypoglycemic episode. After switching to Levemir, managing my basal insulin became much easier and safer. Levemir allows me to split my doses throughout the day and adjust them according to my needs, supporting my body through hormonal fluctuations, stress, and illness.

I am still able to use Levemir, and I am deeply concerned about what will happen when my supply runs out. I am genuinely afraid of experiencing another severe hypoglycemic episode like the one I had in the past.

Other basal insulins are not the same, and removing from the market a medication that works well for so many patients is a serious issue. This decision could lead to increased health risks and higher healthcare costs.

Patients should have access to the medications that work best for them. It feels like we are moving backward in terms of healthcare and support for people living with chronic conditions that require constant, 24/7 management.

Please help us maintain access to the medical care and support we need. We deserve to be heard and to have access to the treatments that help us stay safe and healthy—for ourselves, our families, and the healthcare system as a whole. Michela Belluta

I support the continued availability of Levemir as an option for diabetic patients. Rachael Haines

My son is a T1 Diabetic who has been using Levemir insulin for 9 years. It’s the only insulin that can meet his unique needs. Levemir’s shorter action time make it ideal for people with differing day/night insulin needs as well as those who experience frequent fluctuations in need. Lantus burns and causes the dreaded “Lantus low” Tresiba lasts far too long for him and gave him upper respiratory issues when he was on it briefly years ago. Levemir is a vital insulin. Please help us continue manufacturing it. Jaime Losinski

My son has used Levemir for the past 4 .5 years, and there's no insulin like it that he could switch to. He has used Lantus before (1 shot for 24 hrs), but his insulin needs greatly differ between daytime vs night time, and outside of pumping, which can have it's own issues and has been traumatic for him, there is no other insulin that is safe for him to use without causing hypoglycemia or hyperglycemia. It's the safest option for my son, and losing it would make his life more challenging, with an already challenging lifelong medical condition. Kirill Zenchenko

Hello. I've had type 1 diabetes for close to 30 years. Coming from a time when choices about insulin and management were few and far between, one of the things that has given me the most freedom and control is Levemir. It allows to me eat when I want to, accommodates for fluctuating hormones and day to day changes like no other insulin.

It keeps me safe from unnecessary low blood sugars which can be deadly. There's is nothing comparable on the market. What those without diabetes may not understand is limiting specific choice with insulin is taking away quality of life and safety. I hope the voices of those who depend on this insulin are heard. Please consider and bring it back! Cara Zemel

My name is Scott Strumello, and I have lived with autoimmune Type 1 diabetes mellitus for the past 50 years. I was diagnosed as a 7 year old child. Over the past half-century, I have endured repeated insulin "retirements" whereby efficacious insulin products have been repeatedly and systematically withdrawn from the market (Iletin Semilente, Iletin Lente, Iletin Ultralente, Humulin Semilente, Humulin Lente, Humulin Ultralente, Novolin Semilente, Novolin Lente, Novolin Ultralente to name just a few; there are likely others I cannot recall from memory).

The discontinuation of Novo Nordisk Levemir (insulin detemir injection, 100 units/mL) is merely the latest in a long stream of discontinuations, typically due to expiring Intellectual Property (IP) rights for these molecules. At least in the past, the excuse manufacturers gave was that the new products offered superior glycemic control, but when Levemir's discontinuation was announced, not one basal insulin could point to superior glycemic management as an advantage.

And let's not forget: Insulin detemir remained a substantial product at the time of its withdrawal. According to the Medical Expenditure Panel Survey (MEPS) produced by the U.S. Agency for Healthcare Research and Quality (AHRQ) as of 2022 and derived from the ClinCalc DrugStats database, insulin detemir ranked as the 127th best-selling drug in the United States out of ~2,000 medicines approved by the FDA for sale, with more than 4.8 million prescriptions dispensed to over 900,000 patients. In addition, according to healthcare consulting firm Close Concerns, insulin detemir generated nearly $650 million in U.S. revenue during that same year.

These figures demonstrate that insulin detemir remained an actively utilized therapy serving a substantial patient population and was not merely a legacy product approaching clinical obsolescence. And let me remind FDA: we were promised that the advent of legislation enabling biosimilars would render these product discontinuations moot because other manufacturers could step in to make them with the expiry of IP rights. Instead, we are seeing like 11 different glargine products from multiple manufacturers, and not one detemir biosimilar.

On November 8, 2023, Novo Nordisk announced the planned discontinuation of Levemir in the U.S. The withdrawal was not the result of a newly identified safety concern or regulatory action. Rather, it reflected commercial and strategic considerations prevailing at the time the unilateral corporate decision was made, specifically the company's inability to meet demand for its obesity drugs (which are not World Health Organization designated "essential medicines" as insulin detemir is).

While FDA likes to claim it is powerless to control the actions of commercial entities, in reality, FDA played a role. For example, following the signing of the Biologics Price Competition and Innovation Act (BPCIA) into law, FDA waited for nearly a decade to implemented needed policy changes to enable insulin products to be regulated as the biologic they were, and that excessive delay (the maximum amount of time allowable under the law) played a role by introducing uncertainty for biosimilar manufacturers of any insulin products, and delaying approval decisions (blaming COVID-19 shutdowns instead of FDA's own negligence in necessary policy implementation). There is plenty of blame to be assigned, and FDA rightfully shares in the situation patients now find ourselves in. Scott Strumello

I understand why it may not be cost effective to make levemir insulin available… But the fact of the matter is at one point it was deemed necessary and it still is. Please make levemir insulin available again. Anonymous

To whom it may concern,

It is my opinion & Family experience that insulin must be distributed as well as available according to individual patient requirements. Whether long or short acting affect. Please consider Patients needs before all others. IE, cost, distribution, affect. Sincerely, Bea Walton

My son was started on Lantus (glargine) when he was diagnosed with type 1 diabetes. Due to its acidic pH it stung when injected and he started avoiding his shots. We asked to be switched to Levemir (detemir). It worked so well for him and was instrumental in his excellent blood sugar control throughout puberty.Levemir is a critical insulin for type 1 diabetics and pregnant women with gestational diabetes. Please keep this insulin available for people who need it. Jill Litzinger

I was diagnosed with type 1 diabetes at the age of 50 years old. I spent 3 years using only insulin in pens before transitioning to an insulin pump. That time was so important for me to learn how my body worked with different foods and different activities and for me to feel safe with insulin. Levemir was so important to me during this time. It is a type of insulin that does not have a peak like others and it allowed me to adjust my dose as I gained back weight I had lost prior to diagnosis.

Insulin glargine can cause scary lows in blood sugar and as a mom of two kids when I was diagnosed without another adult living in our home, I was terrified of going so low that I could not assist myself and it would require my kids to step in and save my life. I am so grateful that Levemir was available to me at this time and I would continue to keep it on hand if I could for pump failures. They do happen. Please allow Levemir to be made again. Thank you. Sara Rosen

Hello my Son has autism and type 1 diabetes and he used Lantus for about 6 years. My son suffered from severe Lantus lows so many times I can not count. They would happen right after injection and drop so quickly that Dexcom would not catch the low in time. Before he wore a Dexcom he had a severe low where he became almost unconscious and I had to administer the glucagon shot and call an ambulance. He was 105 before injection of Lantus per a finger stick and within 15 minutes he began acting out of sorts.

I did a finger prick and it said LOW. I gave him glucagon shot because he was not able to eat or drink glucose. We now use Tresbia and do not experience these episodes anymore but I do believe that Levemir should still be manufactured. Everyone is different and there bodies all react differently to these insulins and right now there are only two options to choose from. Tresbia may not be right for pregnant women or those newly diagnosed, especially young children like Aden was when he was first diagnosed.

He was only 2. Levemir is a much gentler insulin that does serve a purpose. And I believe if people were told about dosage correctly, like splitting this insulin in two different times like morning and night, that more would use it and also it would work better for those who have tired it and stopped using. There are still many people who depend on this insulin. Who cannot take Lantus due to the lows and who Tresbia may be too much for them. Diabetics already have so much to handle that they deserve to have options to see which fits better for them because one size does not fit all. Thank you for your consideration in helping diabetics to live a healthy and safe life with less worry. Sarah Ferrara

Not having Levemir Insulin available is a huge concern for me. No other long acting insulin works suitably for me, since Lantus & Tresiba both are manufactured using E-Coli and cause negative effects for me. Levemir used yeast to manufacture the insulin. Lantus & all its generic forms cause me to have irritation along my spinal cord. & the duration of the insulin does not keep my blood sugars anywhere near as stable.

I was on Lantus for my 4th pregnancy & ended up having my placenta rupture & delivered my baby 6 weeks early. It also gives me a constant headache & a feeling of something gnawing on my spine.

Tresiba stays in my system way too long & gives me drastic lows, since the injections overlap in duration. Only time I have ever needed to have paramedics respond to me, was the 2nd week I was trying Tresiba. On my way home from work, I started to go low, missed my turn to my house, and continued on to the next cross street. Ended up passing out behind the wheel, by a guardrail on the opposite side of the street, car still in drive.

Passerby called 911 & a wonderful sheriff came & rescued me. She had to break the passenger window out of my car window to get me out of my car & into the ambulance. My BG was “low” when they first tested it, then 12 mg/dL the 2nd time! Incredible I did not kill myself, wreck my car, or hurt anyone else!

I have been taking insulin for 51 years & that was my first incident where I passed out while driving ever! I will never use Tresiba again! I was thankful that Novo Nordisk gave a warning about discontinuing Levemir, so my Dr wrote my Rx to give me some cushion. But I am terrified of having to use Lantus or Tresiba, all because Novo Nordisk wasn’t making as much money as they wanted too on Levemir.

Please classify Levemir as a drug in urgent need of production in, the US & allow for it to be manufactured here in the States as soon as possible. My cushion is dwindling, and it is a constant concern for me & others who cannot use other long acting insulins! Myrthann Francisco

Levemir has been discontinued and I am on my last months that I have been saving for my child. It is the only insulin he can use as not all Type 1 diabetics are the same. Everybody requires a different way of managing. Specifically, my son was honeymooning for years and Levemir is the only insulin I can change his morning and night dose depending on how much his pancreas is working that day. As he has progressed out of the honeymoon phase, it is so touch go that I CAN NOT use Tresiba.

That formula is really long acting, and you can cause severe hypoglycaemia in my child that I will not be able to fix for 48 hours. It is extremely dangerous. We tried Atlantis when he was first diagnosed and it caused extreme burning and he experienced a few extreme low blood sugar where I thought he might pass out. There is no other insulin that is the same as Levemir.

We are terrified of what is going to happen in a few months when our supply runs out. It is unfair that this is the only drug on the market that can help my child and many other children as well as the only insulin that is approved for pregnant woman, that it is being taken away with no alternative to match. This could even turn into a life and death situation for our loved ones. Please help us. Carrie Robinson

I am writing to ask the FDA to recognize the urgent need for insulin detemir, formerly sold as Levemir, and to take action to help restore access to this medically necessary basal insulin.

Levemir is very important to me because it is a flexible basal insulin that I can manage within an 8-to-12-hour time frame. That flexibility helps me keep my blood glucose at a safe level overnight and during endurance activities such as long-distance running, cycling, and cross-country skiing. With Levemir, I worry less about hypoglycemia and feel safer doing the activities I love.

Levemir has also allowed me, working with my healthcare provider, to maintain excellent blood glucose control. This insulin fits my body and my lifestyle in a way that other basal insulins have not.

I tried Tresiba, but it did not work well for me. I experienced frequent hypoglycemia during endurance training, which made me feel unsafe and took away much of the enjoyment from my activities.

I also tried Lantus as my basal insulin, but I experienced many unexplained episodes of hypoglycemia while using it.

Because I do not have health insurance coverage for an insulin pump, and because I have not tolerated Tresiba or Lantus well, Levemir remains the safest and most effective basal insulin option for me.

I respectfully ask the FDA to treat the loss of insulin detemir as a serious access and patient-safety issue. I urge the FDA to take all available steps to recognize insulin detemir as medically necessary, address the shortage or discontinuation, and help create a pathway for continued production or for a biosimilar or other equivalent option to become available as soon as possible.

Patients like me should not be forced to switch to insulins that cause repeated hypoglycemia or make daily life and physical activity less safe. Please act to restore access to Levemir or an equivalent insulin detemir product.Pascal Lemieux

I use and need Levemir insulin. I used to use Lantus, but abandon it, due to the extreme lows it causes for me. I started using Levemir, and the difference in quantity and intensity of hypo's were noticeable. Apart from having a better control, I found that after major surgery it is easier to adjust my basal with Levemirs 8 hour duration window, then when I had surgery while on Lantus. Anonymous

I had to change from Lantus to Levemir as I experience dangerous lows with Lantus. With Levemir, I can adjust my dosage daily, in accordance with my activities ( eg reduced dose when exercising, hiking; increased dose when under stress or ill) which I cannot do with the alternatives ( eg Tresiba) which are being offered. My diabetes consultant has already warned me that because I am very active I will struggle with Tresiba and will need to keep eating when hiking/ exercising to avoid dangerous hypos.

With Levemir I split my dose as I need different amounts during the day to what I need at night. I will not be able to have the same control over my blood sugar with any other insulin - only Detemir insulin gives the flexibility that enables me to live as near a normal life as possible; without Detemir insulin it will not be possible to maintain the stable, non-diabetic levels that I have maintained for 10 years and I effectively become disabled. Jane Briggs

I am a brittle type one diabetic who was diagnosed in 1982. I have multiple diabetic complications including vision loss, peripheral neuropathy and more recently, diabetic gastroparesis. I have always been a brittle type one diabetic, but things were dramatically worse when diagnosed with Gastroparesis in 2014. I do my absolute best to keep my blood sugars in a safe range to prevent worsening of current complications, as well as developing additional complications.

I currently take three different types of insulin to manage my type one diabetes (Humalog, Humulin R and Levemir). Levemir is the best long acting insulin I have tried thus far. I have attempted to use Tresiba about a year ago, but had very dramatic, low blood sugars when taking less than half the dose of Levemir. I was getting dramatic low blood sugars in the middle of the night, and I was afraid to drive. Due to the duration of this medication, I had no idea how much Tresiba from the day before was still in my system.

I had to go back on Levemir. I also attempted using insulin pump therapy over a year ago, which only uses short acting insulin. I was unable to mimic the basal effect of Levemir and kept having dramatic highs and lows. Years ago when I took Lantus, I never had great blood sugars, and my doctor told me that Levemir was considered a superior insulin and I needed to be on it. I basically started taking Levemir the year it became available. It is shocking that such a necessary medication for type one diabetics can be discontinued.

I appreciate any help with regards to keeping this insulin available. The idea of switching basal insulins to something completely different is terrifying to me. Sincerely, Arlene Francesca Rouquette

Good afternoon, I am writing in support of Levemir basal insulin (or the manufacture of a generic for Levemir). My son has been type 1 diabetic since 5 years old and over the past 10years he has tried other basal insulins, including Lantus and Tresiba. Neither of these basal insulins are suitable for him.

Levemir basal insulin is the only basal flexible enough to cope with changes in the variable physiological insulin needs. The dose can be tweaked up and down and this will take affect that same day. This is the only basal that is capable of this.

Other basals cause numerous lows and especially Tresiba has such a long active profile it can cause 3days of lows as any tweaks down do not take effect until day 3: It is inflexible and causes prolonged hyperglycaemia or prolonged hypoglycaemia.

Levemir is the only basal felixible enough for our son's needs and his variable sporting activities and life in general.

It is also used for women during pregnancy and at our hospital our Endocrinologist said it is the insulin of choice for the newly diagnosed, as any problems ascertaining the correct basal dosage is easily sorted in a timely fashion.

Can you imagine knowing your child's physiological insulin needs have reduced, but we reduced dosage when we trialled Tresiba , it took 3 days of crashing lows before the reduced dose took affect.

Levemir is the only safe and flexible basal insulin. It is used and needed by many t1ds around the world. Thank you. A Muirhead

The use of detemir in pregnancy is supported by a robust randomized controlled trial (RCT) of glycemic, pregnancy, and neonatal outcomes. It has proven safety and efficacy. Detemir is preferentially used in pregnancy by experts over other basal insulins. This preference is in part a function of detemir’s pharmacokinetic characteristics, such as the relatively short half-life that allows for split dosing to help mitigate the morning glucose rise during pregnancy, and its faster metabolism which helps avoid hypoglycemia in the setting of a sudden reduction in insulin resistance post-partum.

Other long-acting insulins have remaining questions about applicability of use in this population. A recent RCT of insulin degludec was not powered to detect a difference between treatments in the maternal safety and pregnancy outcomes and did not report on risk of post-partum hypoglycemia that would be expected with its long duration of action. Florence Brown

I am a concerned Type 1 (insulin dependant) diabetic who will be directly affected by the removal of the long acting insulin, Levemir from manufacture. I use Levemir 3 times daily as my basal insulin to manage my blood glucose levels. The timing of Levemir insulin means that I can adjust my dose multiple times per day/as needed and according to changes in my daily activity, unlike longer acting insulins, such as Lantus, with which I have suffered numerous lows due to their longer duration. Jamie Read

To whom it may concern, please figure out for a quick path forward for detemir/Levemir to be available for patients with Diabetes.

My child has used a pump, tried most of the other basal insulins and found that Levemir works the best for her.

I also have a niece who has gestational diabetes and had Levemir for her first child and was forced to use another methodology with her second. She had great success with Levemir and not complications. The 2nd pregnany was complicated and dangerous for both mom and baby. Complications occurred and blood glucose was volatile due to the new modality used. She doesn’t feel safe to bring another child into this world due to this experience- which is very sad.

Please work to provide options - I liken this to “no one size fits all” people need options. There is an insulin availability crisis on the horizon. We need government’s help to make this happen. With gratitude! Ned Edwards

I am a mom of a 15 year old type 1 diabetic. He was diagnosed 5 years ago. We used levemir until last December. Then switched to Tresiba. It has been 4 stressful months dealing with a much stronger and longer lasting basal insulin. Over night lows and highs have been scary. I have not slept thru the night in 4 months. Levemir was easy to adjust according to his activity level and his growth spirts. I miss Levemir every day. Please bring it back. Tammie Soberg

I am a type 1 diabetic, who was diagnosed in pregnancy. Levemir is the only insulin that works for me. Levemir (insulin detemir) is a very advantageous insulin of choice for people that need to make frequent adjustments in daily dosage, especially women.

Reasons for frequently adjusting dosage are; exercise, hormonal fluctuations, and insulin resistance/sensitivity. Women's hormone levels change daily and I need an insulin that is flexible and easy to adjust within a 24 hour time frame. As a woman of child bearing age, I have benefited from Levemir immensely. When I was diagnosed in pregnancy with gestational diabetes my endocrinologist prescribed me Levemir. It was, and is, the gentlest of all long acting insulins on the market. I had little to no education on the dangers of low blood sugars with long acting insulin use, and had I been prescribed another long acting insulin, my risk of low blood sugar and death would have been increased.

Levemir was the only insulin approved for use in pregnancy. Levemir was safe for me because it has the shortest window of action out of all the other long acting insulins. With Levemir I was able to manage my rapidly changing insulin needs during pregnancy and post-partum with my second child after my type 1 diagnosis. No other insulin on the market can match the short time frame of action to accommodate daily changing insulin needs due to a woman's hormones.

This saved my and my baby's life, as I was able to achieve non-diabetic blood sugars and deliver a healthy baby with no complications. I could adjust my dose daily in a SAFE way due to the short action time of Levemir. As a newly diagnosed type 1, Levemir allowed me to rapidly decrease my dosage, when I experienced low blood sugars from entering my "honeymoon phase" (this is when type 1s experience a short lived rebound in insulin production, once exogenous insulin is introduced, and blood sugars are stabilized).

After two years of stressful life events, Levemir has allowed me to restore my health (again due to its short action time and ease to change daily dosage) as I lose weight. Low blood sugar decreases quality of life with its long list of symptoms, one of which is death. Without Levemir only two long acting insulins will be available to Americans, insulin glargine, and insulin degludec. In addition to the fact that these two options are longer acting and do NOT offer the flexibility in dosing that Levemir provides, both have known side effects as well. For me, being forced to use one of the two alternative insulins, glargine or degludec, would put me at risk for serious risk for life-threatening low blood sugars.

I tried dedludec and that is precisely what happened to me, complications. I experienced serious low blood sugar events as my hormone needs fluctuated and I needed less insulin within a 24 hour period. Degludec's dosage could not be adjusted quickly enough to match my daily insulin needs due to hormones. It is too long acting, and glargine similarly, has a longer action time than Levemir, so poses the same risk to me. The last alternative is to use an insulin pump.

An insulin pump is not a feasible solution for me due to its extremely high cost and adverse skin reactions. Health insurance companies rarely cover these, as insulin pumps are deemed "durable medical equipment" and do not fall under prescription drug coverage. I simply cannot afford one, nor can I tolerate one, as my skin reacts with painful rashes and forms scar tissue when I use wearable devices. I need Levemir. My supply is dwindling. Please consider the NEED many type 1 diabetics have tor Levemir. There is no alternative for me. Megan Vertullo

Insulin detemir remains an essential therapy for many people living with diabetes, and its continued availability is critical for patient safety, treatment stability, and public health. While multiple basal insulins exist, detemir has a unique pharmacokinetic profile that some patients tolerate better than alternatives. For individuals who experience adverse effects, unpredictable glucose patterns, or reduced quality of life on other basal insulins, detemir is not simply interchangeable—it is the only option that provides stable, safe glycemic control.

Discontinuation of detemir would force medically stable patients to transition to different formulations, which carries well‑documented risks: destabilized glucose levels, increased hypoglycemia, higher healthcare utilization, and avoidable clinical complications. These transitions disproportionately affect vulnerable groups, including children, pregnant individuals, and patients with comorbidities who rely on detemir’s predictable action curve.

From a public‑health perspective, maintaining multiple basal insulin options strengthens treatment resilience, reduces the burden on clinicians and emergency services, and supports continuity of care. Preserving access to detemir aligns with the FDA’s mission to protect patient welfare by ensuring that safe, effective, and necessary medications remain available when no true therapeutic equivalent exists for all patients.

For these reasons, I urge the FDA to support the continued availability of insulin detemir to safeguard patient stability, minimize preventable harm, and uphold the diversity of treatment options required for individualized diabetes care. From a CDCES/RN/T1DM patient. Bri Dougall

I’m writing today as a person living with Type 1 diabetes (a ‘baby diabetic’ diagnosed only about 5 years ago) and a physician – trained in epidemiology and working in public health for about 25 years. I’ve been in a patient role since my early 20s due to various acute and chronic medical diagnoses/conditions including Type 1 and a second, rare autoimmune diagnosis about 2 months after TD1 diagnosis – these diseases and their treatments interact and make management of both very challenging. There are so many variables diabetics, especially Type 1s, have to monitor and manage, and so many decisions we have to make daily.

Levemir (detemir) is one of the two insulins I need and use daily (I purchased extra before it was discontinued). I and many other people especially kids take Levemir twice a day so we can adjust the morning and evening dose, as needed, depending on growth, activity, food intake, illness, and monthly hormonal changes for girls and women. I started Levemir in Jan 2023 because my insurance company decided that it would no longer cover the previous long-acting insulin I was using (Lantus).

Even though I was very stressed about this change, it gave me a chance to research options and I chose Levemir specifically because of how it works - it's mechanism of action is so much safer than Lantus because it is absorbed and released slowly and Levemir cannot cause a severe unexpected low glucose episodes like the 'Lantus Low' many people have experienced.

One Lantus Low I had was due to Lantus probably getting injected directly into a blood vessel (which can happen with injected insulin) and about 20 minutes later, this dose of the long-acting Lantus that is supposed to start working slowly and last about 24 hours, dropped my sugar so hard so fast that it caused a dangerous low glucose event that lasted several hours. My heart was pounding, I was shaky and not able to think straight, and I had to keep drinking juice and drank nearly 200 grams of carbs and I had to call family to come and help me and make sure I didn’t pass out, have a seizure, or die.

This one event really traumatized my younger daughter who was with me at home when it happened. It's a good thing that I was not away from home when I had this unexpected severe glucose low. What about the people or times when there is no one to call for help?

This leaves me with either going on an insulin pump or trying the only other remaining long-acting insulin which is active in your body for 3 days which is just absolutely terrifying given the number of unexpected lows I get. Plus I don’t want to try another insulin which could possibly trigger another autoimmune disease or cause the symptoms (e.g. painful muscle spasms) of my neuromuscular autoimmune disease to return. A month ago, because of this Levemir chaos, I tried the Omnipod pump which required a new continuous glucose monitor if I wanted to use the pump’s automated mode.

When using this pump you only need a short-acting insulin so I didn’t use Levemir for about a month. I have never wanted to try a pump for many reasons and though I went into it with preparation and an open mind, the pump trial was horrible and dangerous. I got allergic reactions to both the pump (possibly the nickel in the insertion needle) and the new glucose sensor and weird unexpected serious glucose lows on the pump including one overnight (which are the scariest) that lasted more than 2 hours and took over 80 grams of carbs to fix.

I think what probably happened in this glucose low is that a bunch of insulin from the pump collected under my skin during the evening (when I had unexpected high sugar even though i had given myself insulin) due to the allergic reaction I was having at the site and this gathered up insulin got released into my bloodstream all at once in the middle of the night created the long lasting and dangerous low.

Based on the pump’s data, I had received very little insulin since the evening and there is no way I should have had this low in the middle of the night; so my hypothesis is the best one I’ve got and the pump company had no explanation. I also have several scars on my legs and belly from the pump experience - which is a serious matter because such reactions can cause skin/fat dystrophy which makes that area unusable/dangerous for future insulin administration.

Type 1 feels like THE HARDEST THING I’ve done/am doing and I cannot imagine fully the heavier weight of this disease for children, parents of young T1 diabetics, and pregnant women – groups of people who are generally in more difficult situations and living more complex realities.

Please help me and many others like me by designating insulin detemir as a drug in shortage so we can access this insulin which is safer and more effective for so many of us. S P

After having my two boys, my a1c has skyrocketed to 11.3%. My A1c was 5.5 on Levemir. I'm on Tresiba and really wishing I could go back on Levemir. I get lows on Lantus. I feel the neuropathy pins and needles every now and then. I'm only 38. Help. I tried a pump and got scar tissue from the infusion sites in my abdomen. I didn't like the issues that came with a pump. Rachel Payne

As a T1D of Almost 50 years, first I lived through the loss of $8-15/vial Lente as it was replaced by Levemir. It was a one-to-one swap of 2 1/2 units 3 times a day. The only difference by this patient was a huge price increase. The two products were adaptable, mostly peakless and predictable.

I tried Lantus (glargine) for about six weeks. It was a disaster. Two doses a day totaling 7 units. Didn't last 12 hours. Did have huge peaks often at 2 a.m. resulting in what I call "feed fests" sitting in the middle of my kitchen with orange juice and peanut butter and jelly sandwiches. Very fast weight gain not to mention disrupted sleep while working full-time.

Then the loss of Levemir and Tresiba. Again more expensive and again it stinks. Again I split it but it requires larger doses and yup weight gain. Not predictable. Not effective but yes disruptive. And certainly nor adaptable.Please fix this greed with the three insulin manufacturers and give us Levemir back. Doris Dickson

I have had harmful effects from both Lantus and Tresiba. They both have their flaws unfortunately and there needs to be another option with a better profile. I’ve essentially stopped working out because of how long Tresiba stays in your system plus there is no way to adjust for anything. You have to be a robot and have zero changes in your schedule which is completely ludicrous with three boys. I can’t use a pump with the short acting and workout either because the short acting type of insulin makes me crash even with no insulin on board and turning the pump off 45 minutes prior to exercise. Elliott Harris

I'm writing as a patient whose daily survival depends entirely on Levemir (insulin detemir). I'm urgently requesting that the FDA designate Levemir as a drug in shortage so alternative manufacturing can begin immediately.

There's a real human cost to taking this molecule off the market.

For years, I fought a war inside my own biology every single night, paralyzed by the fear of severe nocturnal hypoglycemia. Levemir ended that volatility and gave me my baseline stability back.

Physiologically, Levemir isn't just an interchangeable commodity that can be seamlessly swap for other basal insulins.

My biology relies specifically on detemir's unique pharmacokinetic profile. Because it uses a 14-carbon myristic acid chain to bind reversibly to albumin, it gives a uniquely smooth, predictable, and linear buffering effect.

When I'm forced to look at alternatives, I'm staring at a dangerous downgrade in care. Degludec (Tresiba) forms massive subcutaneous multi-hexamers with a long half-life. For a patient who needs tight metabolic control, this causes unpredictable stacking and completely strips away my ability to safely titrate doses in real time.

Glargine (Lantus) relies on localized pH shifts to precipitate into microcrystals, making its absorption erratic and highly dependent on local tissue variables.

Forcing metabolically stable patients off Levemir pushes us backward into an era of high-variance, unpredictable care. It's inevitably going to lead to a surge in ER visits and severe hypoglycemic trauma for those of us who just can't replicate our stability on alternative molecules.

The demand for insulin detemir is absolute, and its absence will cause measurable harm. I respectfully urge the agency to execute its mandate to protect public health and designate Levemir as a drug in shortage today.

Achref Gouader

APIC

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