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Novo Nordisk announced Wednesday that its application to sell its once-weekly insulin icodec has been rejected by U.S. Food and Drug Administration.
The FDA sent the Danish pharma giant a complete response letter making requests related to the medication’s manufacturing process and its use for type 1 diabetes. The administration said it could not complete its review until all the requests are made.
Novo Nordisk said in a press release that it does not expect to be able to meet all the requests in 2024.
‘We believe in the potential of once-weekly basal insulin icodec for those living with diabetes who require basal insulin therapy,” said Martin Lange, executive vice president for Development at Novo Nordisk, in a statement. “We will work closely with the FDA to identify the next steps needed to complete the review so we can provide this novel treatment option to adults living with diabetes.’’
Novo Nordisk first submitted its application to the FDA in April 2023. This May, an FDA advisory committee determined that icodec carried a higher risk of hypoglycemia — low blood sugar — for patients with type 1 diabetes, compared with traditional daily insulin.
Icodec is already approved under the brand name Awiqli in the E.U., Canada, Australia, Japan, and Switzerland.
The news is the latest in a series of recent set backs for Novo Nordisk.
The Wall Street Journal reported on Wednesday that the U.S. Federal Trade Commission is getting ready to sue three major pharmacy-benefit managers over how they negotiate prices for drugs including insulin. According to the outlet, Novo Nordisk, along with Eli Lilly, is also under scrutiny for its role in the negotiations.
Also earlier this week, a new analysis found that Eli Lilly’s tirzepatide is more effective for weight loss than Novo Nordisk’s the active ingredient in Ozempic and Wegovy.
A Novo Nordisk spokesperson told Quartz that the study had several limitations including that it did not exclude patients with type 2 diabetes, who may experience weight loss effects differently than patients without diabetes. The study also did not provide information regarding the doses patients were taking.
And finally, President Joe Biden called on Novo Nordisk to cut the prices of their blockbuster diabetes and weight loss drugs, in an op-ed published last week.