EMA panel backs Novo Nordisk haemophilia A drug FREHEMGO

Novo Nordisk (NYSE: NVO) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for FREHEMGO (denecimig), a treatment for haemophilia A (HA) with or without inhibitors, in adults and children.

FREHEMGO is a factor VIIIa mimetic bispecific antibody intended for routine prophylaxis to prevent or reduce bleeding episodes in patients with HA.

The CHMP recommendation is based on the FRONTIER clinical trial program. In the pivotal FRONTIER 2 trial, denecimig reduced annualized bleeding rates compared to prior clotting factor prophylaxis and on-demand treatment. Results from FRONTIER 3, conducted in children under 12, were consistent with efficacy observed in adolescents and adults. Across the program, mean annualized bleeding rates were generally below 1 in the reported phase 3 population, with a substantial proportion of participants experiencing zero treated bleeds.

In the FRONTIER 5 trial, no new safety signals were identified following direct switching from emicizumab to denecimig. The study also showed participant preference for the denecimig delivery device.

"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," said Mike Doustdar, president and CEO of Novo.

In September 2025, Novo Nordisk submitted denecimig to the U.S. Food and Drug Administration via a Biologics License Application.

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