The European Medicines Agency’s CHMP issued a positive opinion for Novo Nordisk’s haemophilia A treatment, FREHEMGO® (denecimig). This recommendation covers adults and children with haemophilia A, including patients with and without inhibitors.
Data from the FRONTIER clinical trial program supported the recommendation. The study showed the drug significantly reduced bleeding rates.
FREHEMGO® is a next-generation factor VIIIa mimetic antibody designed for prophylactic use. It will be the first treatment of its kind to offer flexible dosing schedules of once-monthly, every two weeks, or weekly.
Patients will administer the medication using a pre-filled pen. The European Commission will now review the recommendation for final marketing authorization. Novo Nordisk expects to launch the drug in the first European countries in the fourth quarter of 2026.