CHMP Backs EU Approval of NOVO NORDISK Haemophilia Drug Frehemgo
European regulators' advisory committee recommended marketing authorisation for denecimig, with first European launches planned for the fourth quarter of 2026.
Novo Nordisk (NVO) said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending marketing authorisation for FREHEMGO (denecimig), a treatment for haemophilia A with or without inhibitors in adults and children. The company described it as the first factor VIIIa mimetic offering once-monthly, once-every-two-weeks and once-weekly prophylaxis in a single-use pre-filled pen. Novo expects to launch in the first European countries in the fourth quarter of 2026 and broadly across the EU starting early 2027.
