Published: Nov 09, 2023
By Tristan Manalac
BioSpace
Novo Nordisk will discontinue its long-acting insulin treatment Levemir in the U.S. by the end of next year, the company announced Wednesday.
The decision was driven by “global manufacturing constraints, formulary losses impacting patient access, and the availability of alternative options,” Novo said in a posting on its website. “We will continue to provide Levemir FlexPen and Levemir vials to wholesalers while supplies last, up to the discontinuation dates, but supply disruptions should be expected.”
FlexPen supplies will see disruptions starting in mid-January 2024, leading up to the product’s complete discontinuation by April 1, 2024. Levemir vials will continue to be available beyond that until the full brand is discontinued on Dec. 31, 2024.
Levemir’s discontinuation comes amid strong pressure from U.S. lawmakers to lower insulin prices. In March 2023, Sen. Bernie Sanders (I-VT), chairman of the Committee on Health, Education, Labor and Pensions, wrote to Novo and Sanofi urging them to follow Eli Lilly’s example and lower the costs of their insulin products.
Novo agreed a few days later, announcing that it would cut the list prices for several of its insulin products by up to 75%. In its announcement at the time, the company specifically named Levemir, which would take a 65% price cut. Novo also committed to lowering the prices of Novolin and NovoLog, as well as its unbranded biologics to match the reduced costs of the branded reference products. These new prices are set to take effect on Jan. 1, 2024.
Novo is also facing additional pricing pressure from the Inflation Reduction Act’s Drug Price Negotiation Program. In August 2023, the Centers for Medicare and Medicaid Services announced the first 10 drugs that will be impacted by the negotiations.
The CMS list includes Novo’s insulin products Fiasp and NovoLog, alongside other highly prescribed medicines such as Lilly’s Jardiance (empagliflozin) and Amgen’s Enbrel (etancercept). Novo has reluctantly agreed to participate in the drug price negotiations.
Nevertheless, even as Novo faces price reductions on its insulin products, the company is still enjoying strong sales growth, driven mainly by its weight-loss franchise. In its third-quarter financial report, Novo reported that Wegovy (semaglutide) earned almost $3.1 billion in revenue during the first nine months of 2023. This represents approximately 490% sales growth compared to the prior year period.
Demand for Wegovy is expected to grow even stronger, particularly as Novo appears to be eyeing an expansion into renal and cardiovascular spaces. Last month, the company ended the Phase III FLOW trial ahead of schedule due to strong signals of efficacy in kidney outcomes. In August 2023, Novo reported that Wegovy also cleared the Phase III STEP trial in patients with heart failure with preserved ejection fraction.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at [email protected] or [email protected].
Source: BioSpace
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