Novo Nordisk to Discontinue Levemir for Diabetes Mellitus

Novo Nordisk has announced that it is discontinuing Levemir, the company’s basal insulin containing insulin detemir, which treats glycemic control in adults and children with diabetes mellitus. Novo Nordisk said it will continue providing Levemir vials and the Levemir FlexPen to wholesalers up until the discontinuation dates and while supplies last, but they do anticipate supply disruptions leading up the full product discontinuation at the end of 2024.¹

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“Due to global manufacturing constraints, formulary losses impacting patient access, and the availability of alternative options, Novo Nordisk will be discontinuing Levemir in the US,” the company announced in a statement.¹

Levemir was initially approved by the FDA in 2005 and was subsequently available as a 10-mL multidose vial or via the prefilled pen device, Levemir FlexPen, which was discontinued and replaced by Levemir FlexTouch.² The FDA approved the Levemir FlexTouch insulin delivery pen in 2014.

The product contains a long-acting human insulin analogue indicated to improve glycemic control in adults and children with diabetes mellitus. Levemir FlexTouch is a prefilled pen containing 300 U (3 mL of 100 U/mL) of insulin detemir, which provides doses in 1-U increments, from a minimum of 1 U to a maximum of 80 U per dose. Levemir regulates glucose metabolism by binding to insulin receptors. It lowers blood glucose by assisting glucose transportation into muscle and fat and by decreasing glucose output from the liver.³

In March 2023, Novo Nordisk announced it would cut the US list prices for several insulin products by up to 75%.⁴ These products included pre-filled pens and vials of long-acting, short-acting, and pre-mix insulins Levemir, Novolin, NovoLog and NovoLog Mix 70/30. Specifically, Levemir was reduced by 65% off the current list price. The company also lowered the list prices for unbranded biologics to match the reduced price of the respective branded insulin. These changes were set to go into effect on January 1, 2024.⁴

“We have been working to develop a sustainable path forward that balances patient affordability, market dynamics, and evolving policy changes,” Steve Albers, senior vice president, Market Access and Public Affairs at Novo Nordisk, Inc, said in a March 2023 press release.⁴ “Novo Nordisk remains committed to ensuring patients living with diabetes can afford our insulins, a responsibility we take seriously.”

However, the aforementioned market challenges prompted the recent discontinuation announcement after “careful consideration” by the company.

Novo Nordisk announced the following dates for the gradual discontinuation:

• Mid-January 2024: Supply disruptions of Levemir FlexPen
• April 1, 2024: Discontinuation of Levemir FlexPen
• December 31, 2024: Full brand discontinuation, including Levemir vial

“Our top priority is always the health and safety of the patients that use our products. We made this decision after careful consideration, and are confident that patients will be able to access alternative treatments in the US,” the company said in a statement.¹ “We recommend that healthcare providers talk to their patients about alternative treatment options in advance of this supply disruption and discontinuation to ensure continuity of care.”

References

1. Levemir Discontinuation Notice. Novo Nordisk. Website. https://www.novomedlink.com/diabetes/products/treatments/levemir.html. Accessed November 14, 2023.

2. Novo Nordisk announces US launch of new insulin device Levemir FlexTouch: latest delivery device advancement in the basal insulin category. http://press.novonordisk-us.com/2014-06-19-Novo-Nordisk-Announces-U-S-Launch-of-New-Insulin-Device-Levemir-FlexTouch. Accessed September 2014.

3. Levemir [package insert]. www.novo-pi.com/levemir.pdf. Accessed November 14, 2023.

4. Novo Nordisk to lower U.S. prices of several pre-filled insulin pens and vials up to 75% for people living with diabetes in January 2024. Novo Nordisk. Published March 14, 2023. Accessed November 14, 2023. https://www.novonordisk.com/news-and-media/latest-news/lowering-us-list-prices-of-several-products-.html