USA — Novo Nordisk, a major player in the pharmaceutical industry, has announced plans to discontinue its long-acting insulin treatment, Levemir, in the U.S. by the end of next year.
The decision, communicated through a post on the company’s website, is attributed to a combination of “global manufacturing constraints, formulary losses impacting patient access, and the availability of alternative options.”
Novo Nordisk will continue to supply Levemir FlexPen and Levemir vials to wholesalers until stocks are depleted, up to the specified discontinuation dates.
However, disruptions in FlexPen supplies are anticipated to commence in mid-January 2024, culminating in the complete discontinuation of the product by April 1, 2024.
Levemir vials, another variant of the insulin treatment, will remain available beyond that date until the full brand is discontinued on December 31, 2024.
Levemir’s discontinuation occurs against the backdrop of heightened pressure from U.S. lawmakers to address the soaring prices of insulin.
In March 2023, Senator Bernie Sanders, chairman of the Committee on Health, Education, Labor and Pensions, urged Novo Nordisk and Sanofi to emulate Eli Lilly’s example and reduce the costs of their insulin products.
Responding to this, Novo committed to slashing the list prices of several insulin products by up to 75%, including Levemir, which faced a 65% price cut. These revised prices are set to take effect on January 1, 2024.
Adding to the pricing challenges, Novo Nordisk is grappling with the implications of the Inflation Reduction Act’s Drug Price Negotiation Program.
The Centers for Medicare and Medicaid Services (CMS) identified the first 10 drugs, including Novo’s Fiasp and NovoLog, subject to negotiations. Despite initial reluctance, Novo has agreed to participate in these drug price negotiations.
Interestingly, amidst the price reductions and market dynamics, Novo Nordisk continues to experience robust sales growth, primarily fueled by its weight-loss franchise.
In the third-quarter financial report, Novo disclosed that Wegovy (semaglutide) generated nearly $3.1 billion in revenue during the first nine months of 2023, reflecting a remarkable 490% sales growth compared to the same period the previous year.
The demand for Wegovy is poised to intensify further, with Novo Nordisk signaling a potential expansion into renal and cardiovascular spaces.
Notably, the Phase III FLOW trial was concluded ahead of schedule due to strong signals of efficacy in kidney outcomes, and in August 2023, Wegovy successfully cleared the Phase III STEP trial in patients with heart failure with preserved ejection fraction.
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