Novo Nordisk wins CHMP nod for denecimig in haemophilia A
Novo Nordisk has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), recommending marketing authorisation for FREHEMGO (denecimig) to treat haemophilia A, with or without inhibitors, in both adults and children. The Danish pharma giant expects to begin launches in the first European markets during the fourth quarter of 2026, with a broader EU rollout planned for early 2027.
Denecimig is a bispecific antibody that mimics the cofactor function of factor VIIIa by bridging factor IXa and factor X, restoring the body's thrombin generation capacity and helping blood clot. It is administered subcutaneously and is positioned by Novo as a once-monthly, once-every-two-weeks or once-weekly prophylactic option delivered via a single-use pre-filled pen. The company describes it as the first FVIIIa mimetic to offer all three dosing frequencies in a single device.
Trial data
The CHMP recommendation draws on the FRONTIER clinical programme, which spans five studies across adult and paediatric populations. The pivotal FRONTIER 2 trial, published in the New England Journal of Medicine, showed denecimig significantly reduced the annualised bleeding rate compared with prior clotting factor prophylaxis and on-demand treatment. Across the broader programme, mean annualised bleeding rates were consistently reported below 1, with a substantial proportion of participants recording zero treated bleeds.
Results from FRONTIER 3, which enrolled children under 12, were consistent with those seen in adolescents and adults. The FRONTIER 5 study investigated direct switching from emicizumab, the current standard-of-care bispecific antibody in this space, and found no new safety signals alongside a stated patient preference for the denecimig device.
Mike Doustdar, president and chief executive of Novo, said the recommendation "marks an important advancement for people living with haemophilia A, with or without inhibitors," citing the combination of bleed protection, flexible dosing and prefilled pen as a "differentiated treatment option that can reduce treatment burden."
A Biologics License Application submitted to the US Food and Drug Administration in September 2025 remains under review.
Competitive context
The positive CHMP opinion intensifies the already crowded haemophilia A landscape. Roche's emicizumab (Hemlibra), itself a bispecific antibody that mimics factor VIIIa cofactor activity, has been the dominant non-factor prophylactic since its approval in 2018 and set the benchmark for subcutaneous dosing convenience. Fitusiran, an RNA interference therapy developed by Sanofi, received EU approval in 2023, further broadening the non-replacement options available to clinicians.
The data from FRONTIER 5 suggesting patients prefer the denecimig device over emicizumab's auto-injector will be commercially significant, though head-to-head efficacy comparisons remain indirect. Payers and health technology assessment bodies across Europe will scrutinise whether the annualised bleeding rate advantage and dosing flexibility translate into a health-economic case that justifies market access at premium pricing.
For Novo, the haemophilia franchise carries strategic weight beyond its revenue contribution. The company has maintained a presence in the space for more than four decades, and denecimig represents its push to retain relevance as gene therapies from developers including BioMarin and uniQure continue to mature. Several gene therapy programmes are targeting functional cure in severe haemophilia A, which could ultimately compress the prophylaxis market if durable efficacy data accumulate over coming years.