Novo’s haemophilia drug gets EU approval

Nov 13 (Reuters) – Novo Nordisk said on Friday the European Commission has granted approval for its treatment to prevent or ​reduce the frequency of bleeding episodes ‌in adults and children with haemophilia A, a rare blood disorder. Here are more details: • The drug, branded Frehemgo, is a next-generation antibody designed to mimic ‌the ​activity of the blood-clotting ⁠protein called factor VIII, ⁠according to Novo. It is administered as an under-the-skin injection • Patients with haemophilia A, with or without inhibitors, can choose between ​once-monthly, once-every-two-weeks or once-weekly dosing, Novo said • Haemophilia is a rare genetic bleeding ⁠disorder that impairs the ⁠body’s ability to make blood clots. ​There are different types of haemophilia, with haemophilia ​A caused by a missing or defective ‌clotting factor VIII • The approval is based on results from the clinical trial program testing the drug. In one study, Novo ⁠said the drug significantly reduced annual bleeding rates compared with prior preventive and on-demand treatments in people ⁠with hemophilia ‌A, with or without inhibitors • ⁠Novo plans to launch Frehemgo ​in the ‌first European countries over the ​next year, ⁠it said • The US FDA in October extended its review of the drug due to ongoing remediation work at a manufacturing facility (Reporting by Sneha S K in Bengaluru; Editing by ​Jonathan Ananda)