FDA setback for Novo Nordisk’s once-weekly basal insulin icodec

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) covering the Biologics License Application for once-weekly basal insulin icodec for the treatment of diabetes mellitus, submitted by Denmark’s Novo Nordisk (NOV: N).

The decision follows a negative FDA advisory panel recommendation on the product in May this year, which voted by seven to four against the use of the drug in type 1 diabetics due to concerns about its potential to cause hypoglycemia.

In the letter, the FDA has requests related to the manufacturing process and the type 1 diabetes indication before the review of the application can be completed. Novo Nordisk said it is evaluating the content of the CRL and will work closely with the FDA to fulfil the requests, but does not expect to be able to fulfil the requests during 2024.