StoryRegulatory
Novo Nordisk's US decision on haemophilia drug denecimig slips past third quarter 2026
Novo Nordisk says the US FDA review of denecimig, a treatment for haemophilia A, is still ongoing, so the regulatory decision originally expected in the third quarter of 2026 has not come. The FDA ties the extra time to remediation work at the manufacturing site rather than to the clinical data, and has not set a new date. Novo still aims for a US launch in the first half of 2027.
- Submitted to the FDA in September 2025; the FDA then ran a pre-license inspection of the manufacturing site and gave feedback
- The FDA has not identified deficiencies in the efficacy or safety data, according to the company
- Positive CHMP opinion received on 17 September 2026; EMA marketing approval is still pending
- Denecimig is a bispecific antibody given under the skin to prevent bleeding in adults and children with haemophilia A, with or without inhibitors
- The announcement gives no efficacy or safety figures; the filing rests on the FRONTIER2, FRONTIER3 and FRONTIER4 studies