Baxalta: CHMP Adopts Positive Opinion On OBIZUR - Quick Facts

(RTTNews) - Baxalta Incorporated (BXLT) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of OBIZUR. Baxalta is seeking market authorization in Europe of OBIZUR for the treatment of bleeding episodes in adult patients with acquired hemophilia caused by antibodies to Factor VIII, a very rare and potentially life-threatening acute bleeding disorder.

The CHMP positive opinion is based on a global, prospective, controlled, multi-center Phase II/III open-label clinical trial. OBIZUR was granted orphan-drug designation by the European Commission based on the classification of acquired hemophilia A as a rare disease and the potential for the treatment.