The FDA has accepted for priority reviewSanofi SA’sSNY marketing application for efanesoctocog alfa (BIVV001) for hemophilia A, a rare bleeding disorder.
The target action date for the FDA decision is February 28, 2023.
Sanofi and Swedish Orphan Biovitrum AB BIOVF collaborate on the development and commercialization of efanesoctocog alfa.
The application is supported by data from the pivotal XTEND-1 Phase 3 study. Results were recently presented at the International Society of Thrombosis and Haemostasis Congress.
The data demonstrate clinically meaningful prevention of bleeds and superiority to prior factor prophylaxis based on an intra-patient comparison. Efanesoctocog alfa was well-tolerated, and inhibitor development to factor VIII was not detected. The most common treatment-emergent adverse events were headache, arthralgia, fall, and back pain.
Regulatory submission in the EU will follow the availability of data from the ongoing XTEND-Kids pediatric study, expected in 2023.
Price Action: SNY shares are up 1.52% at $41.32 during the premarket session on the last check Tuesday.
