WASHINGTON (dpa-AFX) - Novo Nordisk (NVO, NOVOB.CO, NOV.DE) has received European Commission marketing authorization for FREHEMGO (denecimig), a next-generation therapy for the routine prophylaxis of bleeding episodes in adults and children with haemophilia A, with or without inhibitors.
The approval marks a significant milestone for the company and expands treatment options for people living with haemophilia A, a rare inherited bleeding disorder caused by a deficiency of clotting factor VIII (FVIII). Patients with the condition face an increased risk of spontaneous and prolonged bleeding, which can lead to joint damage and other serious complications if not adequately controlled.
FREHEMGO is a factor VIIIa mimetic bispecific antibody administered as a subcutaneous injection. Designed to offer greater flexibility and convenience, the therapy can be given once weekly, once every two weeks, or once monthly using a single-use pre-filled pen. The dosing options allow patients and healthcare providers to tailor treatment schedules according to individual needs and preferences.
The European Commission's approval follows clinical data demonstrating the therapy's ability to effectively prevent or reduce bleeding episodes in patients with haemophilia A, regardless of inhibitor status. Inhibitors, which are antibodies that neutralize replacement clotting factors, remain one of the most challenging complications in haemophilia treatment.
Novo Nordisk said it plans to introduce FREHEMGO in the first European markets over the coming year, paving the way for broader patient access across the region.
Beyond Europe, the therapy has already secured approval in Saudi Arabia and remains under regulatory review by the U.S. Food and Drug Administration (FDA) and other health authorities worldwide. Additional approvals could further strengthen Novo Nordisk's presence in the haemophilia market and expand access to the treatment globally.
NVO closed Friday's regular trading at $41.63 up $0.98 or 2.41%. But in the after-hours trading, the stock dropped $0.19 or 0.46%.
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