CHMP recommends EU approval of FREHEMGO as the first factor VIIIa mimetic to offer monthly, biweekly, and weekly dosing through a pre-filled pen for haemophilia A treatment

The Committee for Medicinal Products for Human Use has recommended FREHEMGO® (denecimig) for approval in the EU to treat haemophilia A, or congenital factor VIII deficiency, with or without inhibitors, in both adults and children.

FREHEMGO® stands as the first factor VIIIa mimetic to offer once-monthly, once-every-two-weeks, and once-weekly prophylaxis options through a single-use, pre-filled pen.

Novo Nordisk expects to launch FREHEMGO® in the first European markets during the fourth quarter of 2026, with a broader rollout across the EU beginning in early 2027.

Novo Nordisk announced that the Committee for Medicinal Products for Human Use at the European Medicines Agency has adopted a positive opinion recommending marketing authorization for FREHEMGO® to treat haemophilia A, with or without inhibitors, in adults and children.

FREHEMGO® is a next-generation, bispecific antibody designed to mimic factor VIIIa, intended as routine prophylaxis to prevent or reduce how often bleeding episodes occur in people living with haemophilia A, whether or not they have inhibitors.

The CHMP’s recommendation is based on the FRONTIER trial program. In the pivotal FRONTIER 2 trial, denecimig significantly lowered the annualized bleeding rate compared with prior clotting factor prophylaxis and on-demand treatment among people with haemophilia A, with or without inhibitors. Among children younger than 12, results from FRONTIER 3 aligned with the efficacy seen in adolescents and adults. Across the broader FRONTIER program, denecimig consistently produced low mean annualized bleeding rates, generally under 1 in the reported Phase 3 population, with a substantial share of participants experiencing no treated bleeds at all. In the FRONTIER 5 trial, no new safety signals emerged following a direct switch from emicizumab to denecimig prophylaxis, and the study also found a clear preference among participants for the denecimig delivery device.

Mike Doustdar, president and CEO of Novo Nordisk, said the CHMP’s recommendation builds on the company’s more than 40 years of work in haemophilia and represents an important step forward for people living with haemophilia A, with or without inhibitors. He said the combination of strong bleed protection, flexible dosing options, and a pre-filled pen offers a differentiated treatment that can ease treatment burden and give people with haemophilia A greater freedom in managing their condition.

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

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Related Topics and Keywords

CHMP, FREHEMGO, FREHEMGO® (denecimig), haemophilia A, haemophilia A treatment, Novo Nordisk