BAGSVAERD, Denmark — September 17, 2026

Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorization for FREHEMGO® (denecimig) for the treatment of haemophilia A in adults and children, with or without inhibitors. Denecimig is a next-generation factor VIIIa (FVIIIa) mimetic bispecific antibody designed for routine prophylaxis to prevent or reduce bleeding episodes. If approved by the European Commission, FREHEMGO would be the first FVIIIa mimetic offering once-monthly, once-every-two-weeks and once-weekly dosing through a single-use pre-filled pen.

FRONTIER Program Demonstrates Consistent Bleeding Control

The CHMP recommendation is supported by data from the Phase 3 FRONTIER clinical development program, which evaluated denecimig prophylaxis across pediatric and adult populations with haemophilia A, including patients with inhibitors. In the pivotal FRONTIER 2 trial, denecimig significantly reduced annualized bleeding rates compared with prior clotting-factor prophylaxis and on-demand treatment. Results from FRONTIER 3 in children younger than 12 years were consistent with efficacy observed in adolescents and adults. Across the reported Phase 3 population, mean annualized bleeding rates were generally below one, with a substantial proportion of participants experiencing zero treated bleeds. In FRONTIER 5, no new safety signals were identified following direct switching from emicizumab to denecimig prophylaxis, while participants also reported a clear preference for the denecimig administration device.

Denecimig Offers Flexible Prophylaxis and Pen Administration

FREHEMGO is designed to provide flexible prophylaxis schedules of once monthly, every two weeks or once weekly, potentially allowing treatment frequency to be tailored to individual patient needs. The subcutaneous bispecific antibody is engineered to mimic the cofactor function of FVIIIa by bridging factor IXa and factor X, helping restore thrombin generation and support blood clot formation. FRONTIER2 evaluated monthly and weekly dosing in adults and adolescents aged 12 years and older, while FRONTIER3 assessed monthly and weekly regimens in children below 12 years. FRONTIER4 is evaluating every-two-week dosing and long-term safety across all three regimens. The single-use pre-filled pen is intended to provide a convenient administration option for routine prophylaxis.

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Novo Prepares European Launch of New Haemophilia Therapy

Novo Nordisk expects to launch FREHEMGO in the first European countries during the fourth quarter of 2026, followed by broader European availability beginning in early 2027, subject to regulatory approval and applicable requirements. The CHMP recommendation represents another regulatory milestone for Novo’s haemophilia portfolio after more than four decades of activity in the disease area. Novo submitted a Biologics License Application to the U.S. FDA in September 2025, and denecimig remains under review by other regulatory authorities. With multiple dosing frequencies, subcutaneous delivery and Phase 3 evidence across pediatric and adult populations, FREHEMGO expands Novo’s strategy to provide flexible prophylactic treatment options for people living with haemophilia A, with or without inhibitors.

Source: Novo Nordisk, press release