Novo Nordisk A/S (NYSE: NVO) announced that the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) in response to the Biologics License Application (BLA) for Awiqli, the company’s once-weekly basal insulin icodec for diabetes treatment. The CRL from the FDA highlighted specific requests concerning the manufacturing process and the type 1 diabetes indication for the drug, which need to be resolved before the BLA can be completed. According to Novo Nordisk, the company does not anticipate meeting these requests within the current year.
Awiqli has already received approval for the treatment of both type 1 and type 2 diabetes in the European Union, Canada, Australia, Japan, and Switzerland. It was also recently granted approval in China for type 2 diabetes. The CRL from the U.S. FDA was not unexpected, given that in May 2024, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee determined that the data provided for insulin icodec was insufficient to establish a positive benefit-risk profile for type 1 diabetes. The committee’s review did not extend to the drug’s use in type 2 diabetes.- Flcube.com
