Baxalta’s ADYNOVATE Meets Endpoints in Phase 3 Study of Hemophilia A Patients Under 12 Years of Age

BANNOCKBURN, Ill.--(BUSINESS WIRE)--Baxalta Incorporated (NYSE:BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced initial results from a Phase 3 clinical trial of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)]. ADYNOVATE was approved by the U.S. Food and Drug Administration (FDA) in November 2015 for use in adolescent and adult hemophilia patients (12 years and older) for on-demand treatment and control of bleeding, and prophylaxis to reduce the frequency of bleeding episodes.