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.
Abbott's Amplatzer Piccolo Delivery System receives US FDA clearance and CE Mark
Amphix Bio announces initial closing of USD12.5m seed financing round
BiBBInstruments reports additional US orders during targeted EndoDrill GI launch
Sanofi's efdoralprin alfa receives EU orphan designation for AATD-related emphysema
Black Buffalo partners with Sanova to support regulatory strategy and scientific innovation
Nicox completes key data package for NCX 470 NDA submissions
Immusoft's ISP-002 granted US FDA Orphan Drug Designation in MPS II
Orphan Therapeutics Accelerator signs MoU with Fondazione Telethon
Bioretec wins FDA breakthrough status for biodegradable orthopaedic DrillPin
Amferia raises EUR3.5m to advance antimicrobial wound-care platform