Sanofi: MA in hemophilia A in Japan
(CercleFinance.com) - Sanofi announces that the Japanese Ministry of Health has granted marketing authorization (MA) to Altuviiio, taken once weekly, for the control of bleeding in patients with hemophilia A (factor VIII deficiency).
This approval in Japan is based on positive data from patients with severe hemophilia A, including the pivotal XTEND-1 trial in adults and adolescents, and the XTEND-Kids trial in children under 12.
Altuviiio was also approved on 31 August by the Taiwanese FDA for the treatment of hemophilia A in adults and children. Altuviiio received marketing authorization in the US in February, and in the European Union last May.
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