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The FDA has accepted Sanofi’s supplemental Biologics License Application (sBLA) for ALTUVIIIO, a novel, high-sustained factor VIII replacement therapy for adults and children with hemophilia A. The FDA based the decision on positive final data from the pivotal Phase 3 XTEND-Kids trial in children under 12 with hemophilia A.ALTUVIIIO (efanesoctocog alfa) is the first Factor VIII replacement therapy to offer bleed protection with once-weekly dosing. In February, Sanofi announced that FDA had approved the drug for routine prophylaxis and on-demand treatment to control bleeding episodes. Its use also extends to perioperative management (surgery) for adults and children with hemophilia A.
Sanofi developed in collaboration with Sobi. Barclays projects that the drug will top €2 billion in peak sales.
Supportive findings from XTEND-kids studyThe current FDA approval is supporte…