Press ReleasePress Release: FDA grants efanesoctocog alfa Breakthrough Therapy designation for hemophilia A
The United States Food and Drug Administration (FDA) 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...