Novo: CHMP recommends EU approval of FREHEMGO® (denecimig), the first factor VIIIa mimetic offering monthly, once every two weeks and weekly dosing in a pre-filled pen, for the treatment of haemophilia A

Novo Nordisk A/S FREHEMGO® (denecimig) has been recommended by CHMP for approval in the EU for the treatment of haemophilia A (congenital FVIII deficiency), with or without inhibitors for adults and children FREHEMGO® is the first FVIIIa mimetic to offer once-monthly, once-every-two-weeks and once-weekly prophylaxis in a single-use pre-filled pen Novo expects to launch FREHEMGO® in the first European countries in Q4 2026 and broadly across the EU starting early 2027 Bagsværd, Denmark, 17 September 2026 – Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation for FREHEMGO® (denecimig) to treat haemophilia A...