FDA Approves Sanofi and Sobi’s Altuviiio for Hemophilia A

The FDA has approved Sanofi and Sobi’s Altuviiio for adults and children with Hemophilia A, for use in prophylaxis, perioperative management during surgery and on-demand treatment to control bleeding episodes.

Altuviiio is a replacement therapy for patients with the hereditary bleeding disorder caused by a deficiency in factor VIII, a blood clotting protein.

The agency’s decision was based on results from a phase 3 study, which showed significant bleed protection for participants with severe Hemophilia A.

Altuviiio previously received priority review, Breakthrough Therapy, Fast Track and Orphan Drug designations from the FDA.