FDA accepts efanesoctocog alfa BLA for priority review for people with hemophilia A

The US Food and Drug Administration (FDA) 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. The target action date for the FDA decision is February 28, 2023.

French pharma Sanofi (Euronext: SAN) and Swedish Orphan Biovitrum (STO: SOBI), known as Sobi, collaborate on the development and commercialization of efanesoctocog alfa. Sobi’s shares edged up 1.4% to 233.60 Swedish kronor on the news, while Sanofi was up 2%.

Dr Steve Pipe, professor and director of Pediatric Hemophilia and Coagulation Disorders Program, University of Michigan, commented: “Factor therapy remains a cornerstone of hemophilia treatment, but innovation has been needed in this area to address challenges related to bleed protection and cumbersome treatment regimens. If approved, efanesoctocog alfa can deliver close to normal factor activity levels for the majority of the week, potentially offering a new tier of protection. Such therapeutic benefits would represent important advances in unmet medical needs for people with hemophilia A and may transform the prophylactic treatment landscape.”