Sanofi gets USFDA breakthrough therapy designation for hemophilia A drug Efanesoctocog alfa
Hemophilia A occurs in about one in 5,000 male births annually, and more rarely in females.;
Paris: Pharma major, Sanofi, has recently announced that the United States Food and Drug Administration (USFDA) has granted Breakthrough Therapy designation to efanesoctocog alfa (BIVV001) for the treatment of people with hemophilia A, a rare and life-threatening bleeding disorder, based on data from the pivotal XTEND-1 Phase 3 study. Sanofi and Sobi collaborate on the development and commercialization of efanesoctocog alfa.
Breakthrough Therapy designation is designed to expedite the development and review of drugs in the US that target serious or life-threatening conditions. Drugs qualifying for this designation must show preliminary clinical evidence that the drug may demonstrate a substantial improvement on clinically significant endpoints over available therapies.
John Reed, MD, PhD, Global Head of Research and Development at Sanofi said, "The Breakthrough Therapy designation highlights efanesoctocog alfa's potential to transform treatment for people with hemophilia A by providing higher protection for longer duration. This potential new class of factor VIII therapy represents how we are boldly advancing science to address unmet needs for the hemophilia community. We are excited to work with regulatory authorities during the filing and review of this innovative therapy."
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