Sanofi's Hemophilia Candidate Goes Under Priority FDA Review

  • The FDA has accepted for priority review Sanofi SA's SNY 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. 
  • Also Read: Sanofi Ends Development Of Breast Cancer Drug Amcenestrant After Trial Failure.
  • 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.
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