The recommendation is based on the FRONTIER trial programme. In the pivotal FRONTIER 2 trial, denecimig significantly reduced annualised bleeding rates compared with participants’ previous clotting factor prophylaxis and on-demand treatment. Novo says bleeding rates were generally below one in the phase 3 population, with many participants having no treated bleeds. Results in children under 12 (FRONTIER 3) were consistent with those in adolescents and adults. In FRONTIER 5, no new safety signals emerged when patients switched directly from emicizumab.

The opinion now goes to the European Commission for a final decision, which typically follows within about two months. Novo expects to launch Frehemgo in the first European countries in Q4 2026 and more broadly across the EU from early 2027.

CEO Mike Doustdar said: “The recommendation by the CHMP for approval of FREHEMGO builds on Novo’s commitment of over 40 years in haemophilia and marks an important advancement for people living with haemophilia A, with or without inhibitors.”