FDA Delays Novo Drug
FDA Extends Review of Novo Nordisk Hemophilia Drug Over Manufacturing Facility Issues
Anonymous
The FDA has extended its review of Novo Nordisk’s denecimig, an investigational treatment for hemophilia A, because remediation work is continuing at a manufacturing facility. The agency has not provided a new date for a decision after Novo’s expected third-quarter 2026 review window passed. Novo said the FDA has identified no concerns with the drug’s clinical safety or efficacy data and that it is addressing the agency’s manufacturing-related feedback. The company is still aiming for a U.S. launch in the first half of 2027.
Key Points
1
Denecimig is designed to mimic activated factor VIII by bringing clotting factors IXa and X together, and is administered by injection under the skin. Novo has studied weekly, every-two-weeks and monthly dosing schedules.
2
Novo’s application covers adults and children with hemophilia A, including patients who have developed inhibitors against factor VIII treatment.
3
Novo said the extended review does not affect its 2026 financial outlook.
4
The FRONTIER clinical program includes studies in adults and adolescents and in younger children, as well as an open-label extension intended to assess longer-term safety.
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