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

The European Medicines Agency adopted a positive opinion recommending marketing authorization for FREHEMGO (denecimig) for the treatment of haemophilia A, including patients with or without inhibitors. The recommendation is a meaningful regulatory milestone that could expand treatment availability in Europe, subject to final European Commission approval.