FDA Asks Novo Nordisk For More Information On Semaglutide Label Expansion Application

The FDA has issued a Refusal to File letter covering Novo Nordisk A/S' NVO label expansion application for once-weekly semaglutide 2.0 mg to treat type 2 diabetes, which was filed on 20 January.

• The FDA has requested additional information in the letter, including data relating to a proposed new manufacturing site.
• The company will resubmit the application to FDA during the second quarter of 2021.
• Though there is a requirement for additional information for resubmission, Novo Nordisk believes the already completed trial program will be sufficient for approval of the label expansion application.
• Price Action: NVO shares are trading 1.59% lower at $69.92 in premarket on the last check Tuesday.