Danish pharmaceutical company Novo Nordisk A/S (CPH:NOVO-B) (NYSE:NVO) revealed on Wednesday that the US Food and Drug Administration (FDA) has issued a Complete Response Letter relating to the Biologics License Application for once-weekly basal insulin icodec for the treatment of diabetes mellitus.

The FDA requested additional information concerning the manufacturing process and the type 1 diabetes indication.

Novo Nordisk said that it will work closely with the FDA to address the requests but does not expect to be able to do so in 2024.

Insulin icodec is approved for both type 1 and type 2 diabetes in the European Union, Canada, Australia, Japan and Switzerland, and for type 2 diabetes in China.