Novo's Denecimig Gets CHMP Nod for Hemophilia A in the European Union

Novo NVO announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending the approval of denecimig (Mim8) for the treatment of hemophilia A, with or without inhibitors, in adults and children. Denecimig is a next-generation factor VIIIa (FVIIIa) mimetic bispecific antibody designed to prevent or reduce bleeding episodes through routine prophylactic treatment. The therapy is designed to offer flexible dosing options, including once-monthly, every-two-week and weekly administration. It is administered subcutaneously and is being developed as a prefilled pen, which could provide greater convenience compared with conventional treatment approaches.