US FDA extends review of Novo Nordisk's hemophilia drug over facility issues
NVO•The FDA extended its review of Novo Nordisk’s experimental hemophilia A drug denecimig because of ongoing remediation work at a manufacturing facility. Novo said the delay does not affect its 2026 financial forecast and it still aims to launch the drug in the US in the first half of 2027, subject to approval.
1. Review extended
The FDA extended its review of Novo Nordisk’s application for denecimig, which the company is seeking to use to treat adults and children with hemophilia A, with or without inhibitors. The company said the extension is due to remediation work at a manufacturing facility.
2. No new decision timeline
The FDA has not set a new decision date. Novo said the agency raised no concerns about clinical-trial safety or effectiveness data, and that the facility issues do not affect its other marketed medicines. CEO Mike Doustdar said Novo is addressing the FDA’s requests and continuing to work with the agency.
3. Launch aim unchanged
Novo submitted the application in September 2025 and had expected an FDA decision in the third quarter of 2026. The company still aims to launch denecimig in the US in the first half of 2027, subject to regulatory approval, and said the delay would not affect its 2026 financial forecast.
