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Basal Insulin

July 10, 2024

Novo Nordisk’s QW Insulin Icodec Receives CRL

Here is a brief preview of this blast: Novo Nordisk announced FDA issued a CRL regarding the QW insulin icodec BLA for the treatment of diabetes. According to the press release, the CRL outlines requests related to the manufacturing process and the T1DM indication. Novo stated it is evaluating the content of the CRL and will work closely with FDA to fulfill the requests. Of note, Novo does not expect to be able to fulfill the requests during 2024. Below, FENIX provides brief thoughts on the CRL in the context of the recent negative FDA adcom vote.