The U.S. Food and Drug Administration has accepted for priority review the Biologics License Application (BLA) for efanesoctocog alfa (BIVV001) for the treatment of hemophilia A, a rare and life-threatening bleeding disorder, Sanofi - Aventis Groupe said in a statement.
The FDA decision date for efanesoctocog alfa, an investigational factor VIII therapy, is set for February 28, 2023.
The Priority review is based on pivotal data from the XTEND-1 Phase 3 study. The study results demonstrated efanesoctocog alfa's ability to reduce annualized bleeding rates, which supports its potential as a therapy with best-in-disease efficacy.
Sanofi and Sobi collaborate on the development and commercialization of efanesoctocog alfa.
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