Novo wins EU approval for FREHEMGO in haemophilia A
- The European Commission authorised denecimig for routine prophylaxis in adults and children with haemophilia A, with or without inhibitors.
- The dosing options are once monthly, every two weeks or weekly, administered using a single-use pre-filled pen.
- In the FRONTIER2 trial, denecimig significantly reduced annualised bleeding rates versus prior prophylaxis and on-demand treatment.
- Novo plans to launch the treatment in its first European countries in the year ahead.
EU authorisation
The European Commission has authorised Novo’s FREHEMGO® (denecimig) for routine prophylaxis to prevent or reduce bleeding episodes in adults and children with haemophilia A, with or without inhibitors. The decision followed a positive opinion from the European Medicines Agency’s CHMP in September 2026. Novo plans to launch in its first European countries in the year ahead.
Dosing and clinical evidence
The subcutaneous FVIIIa mimetic bispecific antibody can be given once monthly, every two weeks or weekly using a single-use pre-filled pen. In the pivotal FRONTIER2 trial, denecimig significantly reduced annualised bleeding rates compared with prior clotting factor prophylaxis and on-demand treatment. Results in children under 12 in FRONTIER3 were consistent with those in adolescents and adults. Across the FRONTIER programme, mean annualised bleeding rates were consistently low, and a substantial proportion of participants had no treated bleeds.
Regulatory status and mechanism
In FRONTIER5, switching directly from emicizumab showed no new safety signals. Denecimig bridges Factor IXa and Factor X to mimic FVIIIa’s cofactor function and support thrombin generation. The treatment is also approved in Saudi Arabia and is under review by the US FDA and other regulatory authorities.
Source: Novo Nordisk