Novo Nordisk: FDA applications for icodec

(CercleFinance.com) - Novo Nordisk reports that the US FDA has issued a Complete Response Letter (CRL) covering its Biologics License Application for the once-weekly basal insulin icodec for the treatment of diabetes mellitus.


In it, the FDA makes requests related to the manufacturing process and the type 1 diabetes indication, before the review of the dossier can be completed, requests which the Danish laboratory does not expect to be able to respond to in 2024.

Novo Nordisk submitted its dossier to the FDA in April 2023. Insulin icodec is approved under the brand name Awiqli in the EU, Canada, Australia, Japan and Switzerland for type 1 and type 2 diabetes, and in China for type 2 diabetes.


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