Once-weekly Altuviiio approved in Japan

Having gained US and Taiwan regulatory approval for its hematology drug Altuviiio (efanesoctocog alfa) earlier this year, French pharma major Sanofi (Euronext: SAN) has now bagged marketing clearance in Japan.

The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for Altuviiio [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein], a first-in-class, high-sustained factor VIII replacement therapy. Altuviiio is indicated for control of bleeding tendency in patients with hemophilia A (factor VIII deficiency).

Sanofi, which is developing Altuviiio with Swedish Orphan Biovitrum (STO: SOBI), says it is the first and only hemophilia A treatment that delivers normal to near-normal factor activity levels (over 40%) for most of the week with once-weekly dosing in adults and adolescents, and significantly reduces bleeds compared to prior factor VIII prophylaxis in adults and adolescents with severe hemophilia A.