Novo Nordisk receives Complete Response Letter in the US for once-weekly basal insulin icodec

Bagsværd, Denmark, 10 July 2024 – Novo Nordisk today announced that 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. 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 is evaluating the content of the CRL and will work closely wit ...