Novo: CHMP backs FREHEMGO (denecimig) for haemophilia A with monthly, biweekly and weekly dosing in a pre-filled pen
- CHMP recommended marketing authorisation for FREHEMGO (denecimig) to treat haemophilia A in adults and children, with or without inhibitors.
- Denecimig is an FVIIIa mimetic bispecific antibody delivering once-monthly, once-every-two-weeks (Q2W) and once-weekly subcutaneous dosing via a single-use pre-filled pen.
- FRONTIER pivotal trials showed significant reductions in annualised bleeding rate versus prior factor prophylaxis and on-demand treatment; mean ABRs were generally below 1 and many participants had zero treated bleeds.
- Novo plans initial launches in select European countries in Q4 2026 and broader EU rollout from early 2027; a US BLA was filed in September 2025.
Regulatory status
The CHMP of the European Medicines Agency has adopted a positive opinion recommending marketing authorisation for FREHEMGO (denecimig) for treatment of haemophilia A, with or without inhibitors, in adults and children. The Marketing Authorisation Application was supported primarily by data from the FRONTIER clinical programme. Novo has also submitted a Biologics License Application to the US FDA (September 2025).
Clinical evidence
The CHMP recommendation is based on the FRONTIER trials. In the pivotal FRONTIER 2 trial, denecimig significantly reduced annualised bleeding rate compared with prior clotting factor prophylaxis and on‑demand treatment. FRONTIER 3 data in children under 12 were consistent with adolescent and adult results. Across the phase 3 programme mean ABRs were generally below 1, with a substantial proportion of participants experiencing zero treated bleeds. FRONTIER 5 found no new safety signals after direct switching from emicizumab and reported clear preference for the denecimig device.
Product profile
FREHEMGO (denecimig) is a next‑generation FVIIIa mimetic bispecific antibody administered subcutaneously. It ‘mimics’ FVIIIa by bridging factor IXa and factor X to restore thrombin generation, and is supplied in a single‑use pre‑filled pen enabling monthly, Q2W and weekly prophylaxis regimens.
Launch timeline
Novo expects launches in the first European countries in Q4 2026 and broader availability across the EU beginning early 2027.
Source: Novo Nordisk