(CercleFinance.com) – Sanofi announces that the Japanese Ministry of Health has issued a marketing authorization (MA) for Altuviiio once a week, for the control of bleeding in patients with hemophilia A (deficiency in factor VIII).
This approval in Japan is based on positive data obtained in patients with severe hemophilia A, including those from the pivotal XTEND-1 trial in adults and adolescents and the XTEND-Kids trial in children. under 12 years old.
Altuviiio was also approved on August 31 by the Taiwan FDA for the treatment of hemophilia A in adults and children. As a reminder, it was the subject of marketing authorization in the United States in February and in the European Union last May.
‘Altuviiio embodies Sanofi’s promise to develop medicines that are first and best in class,’ said Brian Foard, Acting Executive Vice President, Global Head, Specialty Medicine.