The U.S. FDA has issued a complete response letter to Novo Nordisk's BLA for its once-weekly basal insulin icodec for diabetes treatment.
According to Novo Nordisk, the agency's requests in the CRL were related specifically to the type 1 diabetes indication and manufacturing process.
Novo had submitted the application for insulin icodec to the FDA back in April 2023. In May 2024, an FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 7-4 against the approval of the once-weekly insulin in type 1 diabetes. The panel determined that the data available were not sufficient to conclude on a positive benefit-risk, specifically calling out the increased risk for hypoglycemia in people with type 1 diabetes.
Insulin icodec is already approved under the brand name Awiqli in the EU, Canada, Australia, Japan and Switzerland for the treatment of both type 1 and type 2 diabetes and in China for the treatment of type 2 diabetes.
Novo says it is evaluating the content of the CRL and will work closely with the FDA, but that it does not expect to be able to fulfil the requests during 2024.
