EC approves Sobi’s Altuvoct for hemophilia A

The European Commission has granted marketing authorization for Altuvoct (efanesoctocog alfa), for the treatment and prevention of bleeds and perioperative prophylaxis in hemophilia A.

Developed by Swedish Orphan Biovitrum (STO: SOBI), also known as Sobi, Altuvoct is a high-sustained factor VIII replacement therapy for all ages and any disease severity. Children, adolescents, and adults can experience non-hemophilia factor VIII activity levels (above 40%) for a significant part of the week with once-weekly prophylaxis, reaching trough levels of 15% in adults and adolescents before the next dose. This results in significantly improved protection from bleeds compared to prior factor VIII prophylaxis, Sobi noted.

Efanesoctocog alfa was approved by the US Food and Drug Administration under the brand name Altuviiio last year. Sobi is collaborating with French pharma major Sanofi (Euronext: SAN) on the development and commercialization of efanesoctocog alfa in the USA.