Novo’s FREHEMGO Haemophilia A treatment has reached a major regulatory milestone following a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Announced on 17 September 2026 from Bagsværd, Denmark, the CHMP recommended granting marketing authorization for FREHEMGO® (denecimig) as a routine prophylaxis to prevent or reduce bleeding episodes in adults and children with congenital factor VIII deficiency (haemophilia A), both with and without FVIII inhibitors.
FREHEMGO® is a next-generation factor VIIIa mimetic bispecific antibody designed to be administered subcutaneously under the skin. The therapy operates by bridging factor IXa and factor X, thereby mimicking the essential cofactor role of FVIIIa to restore the body’s natural thrombin generation capacity and facilitate normal blood clotting without the need for clotting factor replacements.
As the first FVIIIa mimetic offering once-monthly, once every two weeks (Q2W), and once-weekly dosing options in a single-use pre-filled pen, FREHEMGO® provides a flexible treatment alternative aimed at reducing treatment burden and offering individuals living with haemophilia A greater independence.
Clinical Trial Evidence for Novo Nordisk FREHEMGO Haemophilia A Prophylaxis
The positive recommendation from the CHMP is based on findings from the global Phase 3 FRONTIER clinical trial programme. In the pivotal FRONTIER 2 study in participants aged 12 years and older, denecimig demonstrated statistically significant reductions in annualized bleeding rates (ABR) compared to prior clotting factor prophylaxis and on-demand treatment in individuals with haemophilia A, with or without inhibitors.
In pediatric patients under 12 years of age, data from the FRONTIER 3 study showed efficacy results that were consistent with those seen in adolescent and adult cohorts. Across the FRONTIER program, denecimig consistently maintained mean Phase 3 ABR levels below 1, with a high proportion of study participants experiencing zero treated bleeding events.
Transition dynamics and safety were specifically assessed in the FRONTIER 5 trial, which demonstrated no new safety signals when participants directly switched from emicizumab to denecimig prophylaxis, alongside a clear user preference for the denecimig pre-filled pen device. Long-term safety and efficacy for the bi-weekly schedule were evaluated in the FRONTIER 4 open-label extension trial across all three dosing regimens.
Mike Doustdar, president and CEO of Novo, noted that the recommendation builds on four decades of company experience in haemophilia care. Following this positive opinion, commercial launch of FREHEMGO® is expected in initial European countries in Q4 2026, with broader availability across the EU planned for early 2027. This follows the Biologics License Application (BLA) submitted to the US Food and Drug Administration (FDA) in September 2025.
