Sobi Reports Positive CHMP Opinion For Efanesoctocog Alfa - Quick Facts

(RTTNews) - Swedish Orphan Biovitrum AB announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending approval of efanesoctocog alfa, for the treatment and prevention of bleeds and perioperative prophylaxis in haemophilia A. The recommendation is based on the results from the pivotal phase 3 studies: XTEND-1 in adults and adolescents and XTEND-Kids in children, which evaluated the efficacy and safety of efanesoctocog alfa.

Efanesoctocog alfa was first approved in the US in February 2023 by the FDA. The FDA previously granted efanesoctocog alfa Breakthrough Therapy designation in May 2022, Fast Track designation in February 2021, and Orphan Drug designation in 2017.

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