CHMP Recommends EU Approval of Novo Nordisk's FREHEMGO (denecimig) as First Factor VIIIa Mimetic
核心洞察
The CHMP has recommended EU marketing approval for FREHEMGO (搜索) (denecimig), described as the first factor VIIIa (搜索) mimetic bispecific antibody for haemophilia A (搜索).
The recommendation is based on the FRONTIER2, FRONTIER3 and FRONTIER4 trials, which supported the denecimig Marketing Authorisation Application submission.
FREHEMGO (搜索) is administered subcutaneously and is designed to provide once-monthly, every-two-weeks and weekly prophylaxis in patients with or without inhibitors.
The Committee for Medicinal Products for Human Use (CHMP) has recommended EU approval of FREHEMGO (搜索) (denecimig), the first factor VIIIa (搜索) mimetic bispecific antibody, according to Novo. The product is currently pending marketing approval from the EMA and other regulatory authorities.
FREHEMGO (搜索) is an FVIIIa mimetic bispecific antibody designed to deliver once monthly, every two weeks and weekly prophylaxis for people living with haemophilia A (搜索), with or without inhibitors. Administered under the skin, it "mimics" the role of FVIIIa by bridging factor IXa (搜索) and factor X, mimicking the cofactor function of FVIIIa to help restore the body's thrombin generation capacity and support blood clotting.
The Marketing Authorisation Application was based on the FRONTIER2, FRONTIER3 and FRONTIER4 trials. FRONTIER2 evaluated once-monthly and once-weekly denecimig in adults and adolescents aged 12 years and older, while FRONTIER3 evaluated the same regimens in children below 12 years. FRONTIER4 was an open-label extension trial assessing once-every-two-weeks efficacy and long-term safety across all dosing regimens in subjects with haemophilia A (搜索), with or without inhibitors. The broader FRONTIER programme (FRONTIER1-5) investigates denecimig as prophylaxis to prevent bleeding episodes across paediatric and adult populations.