Novo Nordisk says FDA extends denecimig BLA review for manufacturing remediation
NVO•The FDA extended its review of Novo Nordisk’s denecimig application for hemophilia A, citing remediation work at a manufacturing facility identified during a pre-license inspection. Novo said its 2026 financial outlook is unchanged and it targets a U.S. launch in the first half of 2027, pending FDA action.
1. Review remains ongoing
Novo Nordisk said the FDA has not provided a new decision timeline for denecimig. The agency flagged no deficiencies in the clinical efficacy or safety data submitted with the application; the review extension is tied to manufacturing facility remediation.
