The European Medicines Agency’s CHMP recommended approval for Novo Nordisk’s hemophilia A therapy, Frehemgo (denecimig). The endorsement covers treatment for both adults and children, including patients with or without inhibitors.
The CHMP based its opinion on results from the FRONTIER clinical trial program. Data from these trials showed that Frehemgo significantly reduced patient bleeding rates.
This recommendation precedes the final marketing authorization decision from the European Commission. Novo Nordisk expects to launch the therapy in the first European countries by the fourth quarter of 2026.