The European Medicines Agency’s CHMP gave a positive opinion for Novo Nordisk’s hemophilia A drug Frehemgo (denecimig/Mim8), recommending it for routine prophylaxis to prevent bleeding episodes in adults and children, with or without inhibitors.
The recommendation came from the CHMP’s 14–17 September 2026 meeting and is a scientific opinion, not the final EU marketing authorization; the European Commission makes the binding decision.
The same CHMP meeting backed seven other new medicines and also recommended extensions of use for multiple existing medicines.
Novo said it expects to launch Frehemgo in the first European countries in Q4 2026, with broader EU rollout in early 2027.
Sources:
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