COPENHAGEN — Novo Nordisk announced Oct. 2 that the FDA's review of its Biologics License Application for denecimig remains ongoing due to manufacturing facility remediation, with no new timeline communicated for regulatory action.
The company had anticipated an FDA decision in the third quarter of 2026. It now targets a U.S. launch in the first half of 2027, contingent on approval.
Critically, the FDA identified no deficiencies in the clinical efficacy or safety data submitted for denecimig. The hold concerns only the manufacturing site; remediation does not affect other Novo Nordisk marketed products.
Novo Nordisk submitted the BLA in September 2025 for denecimig, which treats hemophilia A in adults and children with and without inhibitors.
Denecimig received a positive European regulatory committee opinion on Sept. 17. Marketing approval in Europe remains pending.
Novo Nordisk said the extended U.S. review does not affect its 2026 financial outlook.
