US FDA requests additional info on manufacturing, type 1 diabetes indication for Novo Nordisk's once-weekly basal insulin icodec.
Novo Nordisk received a Complete Response Letter from the US FDA regarding the Biologics License Application for its once-weekly basal insulin icodec for diabetes treatment. FDA requested additional information on the manufacturing process and type 1 diabetes indication before reviewing the application. Novo does not expect to fulfill these requests in 2024 and will work closely with the FDA to identify next steps.
July 10, 2024
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