Latest news with #Levemir
Yahoo
05-06-2025
- Health
- Yahoo
Opinion: When the insulin that works disappears
I remember being in a college pathology class when the professor told us we should learn about type 1 diabetes, since it was likely to impact someone we knew. Then he said something else that I didn't fully understand at the time: the insulin market was becoming more concentrated, with fewer companies producing it, which was leading to fewer options and rising prices. Fast forward nearly 30 years later, and my 13-year-old daughter was diagnosed with type 1 diabetes. We struggled at first. But after a few difficult months, we found a system that worked — involving lifestyle changes and the use of a specific long-acting insulin called Levemir (detemir). Levemir has a shorter and more predictable action than the few alternative long-acting insulins. That made it ideal for my daughter, an athlete navigating not just intense physical activity but also the fluctuating insulin needs that come with puberty and hormone fluctuations. We found a rhythm and felt in control again. Then, two years into her diagnosis, that sense of control was ripped away. On November 8, 2023, we learned that Novo Nordisk planned to discontinue Levemir in the U.S. I was shocked. Levemir had been widely available since 2005. Surely, I thought, someone would step in to fix this. But the more I learned, the more alarmed I became. Levemir is the long-acting insulin that has been most proven safe in pregnancy, where maintaining tight blood glucose control can help prevent early delivery, high blood pressure and large birth weight. Removing it from the market could put pregnant women with diabetes at real risk. I connected with physicians and advocates who were sounding the alarm. I started a petition. I joined with others also affected, and we formed a nonprofit — The Alliance to Protect Insulin Choice — and began traveling to Washington, D.C., often to meet with congressional and regulatory offices. Largely due to our efforts, a company is now seeking to manufacture a biosimilar version of Levemir. But funding has been difficult. Historically, no insulin removed from the market has successfully come back as a biosimilar, and the regulatory path remains unclear. That must change — especially for a drug so critical to pregnancy and pediatric care. Levemir isn't just a niche preference. It was the 127th most prescribed drug and used by just under one million people in 2022. It's still available in other countries. It's the only long-acting insulin that can be diluted, making it vital for infants and small children who need extremely precise doses. It also leads to less weight gain than its alternatives and causes less discomfort during injection because it isn't acidic. The FDA knows that not every drug works the same for every person. Just last year, in response to a penicillin shortage, the agency worked with manufacturers, explored foreign supply chains and increased domestic production. We're asking for the same urgency. We need the FDA to act — to ask Novo Nordisk to permit U.S. access to Levemir from abroad, and to support the company trying to bring a generic version to market. Insulin is not optional. Less than half of people who require insulin use insulin pumps, and many pump users rely on long-acting insulin as a backup. Without Levemir, many patients will be forced onto one of the few alternatives that might not work as well for their bodies and lives. Imagine if a common pain reliever was suddenly pulled from the market — not for safety reasons, but because it was no longer as profitable. There would be outrage. So why is there so little outcry when this happens to a drug that literally keeps people alive? We're asking for fairness, for choice and for a healthcare system that puts patients before profits.
Time of India
22-04-2025
- Business
- Time of India
Novo Nordisk to phase out key drug, insulin cos spot big biz opportunity
As Novo Nordisk prepares to phase out some forms of its human premix insulin brand Mixtard-a move seen overlapping with its planned launch of weight-loss drug Wegovy in India-other top insulin makers are rushing to ramp up production capacity to bridge the potential demand-supply gap the move is expected to create, said top company executives. The Danish pharma major, the maker of semaglutide blockbusters Ozempic and Wegovy, is planning to retire a range of insulin formulations available in easy-to-use disposable pen and cartridge forms by the end of this year. This would include human insulin in penfill and flexpen, including Mixtard 30 Penfill and Flexpen, Actrapid Penfill and Flexpen, Insulatard Penfill and Flexpen, and Mixtard 50 Penfill over the next six months. It will also phase out insulin brand Levemir in FlexPen and Xultophy FlexTouch (Insulin + GLP1). The company recently informed Abbott India about this planned phase-out, according to a document accessed by ET. Abbott is the marketing partner for Novo's insulin. Confirming the development, a Novo Nordisk spokesperson said, "In order to meet increasing patient demand and ensure a stable supply of our medicines, we have decided to consolidate our insulin portfolio, as this will create space needed in our global manufacturing network. Hence, in this process, we are phasing out the penfill." However, the company said it is not discontinuing Mixtard in India and "it will continue to be available in vials". The company did not provide any details on specific brands. "Along with it, other forms of insulins, including human insulins from Novo Nordisk, will continue to be available in vials and devices for patients across India," the spokesperson said. "With the decision, we strive not to leave any patients without alternative treatment options, either from Novo Nordisk or other companies. It is important to us that the transition to other devices or treatment options is as smooth as possible for patients." The phasing out of the penfill Mixtard creates an opportunity for other human premix insulin makers such as Lupin , Eris, Eli Lilly, Wockhardt and Cadila , said industry insiders. Amit Bakshi, MD, Eris Lifesciences , which is ramping up capacity to produce penfill insulin said, "Our strategy is to make sure how we are available through and through and how we can ramp up manufacturing." However, according to him the transition phase may be a "small level of emergency", as a lot of hoarding has been happening in the last couple of months after the news has been out, with several large stockists and patients increasing their stock. "We may not be able to take on all of the demand immediately but are planning to take 60-70% of it."
