Baxalta was granted Marketing Authorization for OBIZUR [Antihaemophilic Factor (Recombinant), Porcine Sequence] by the European Commission for the treatment of bleeding episodes in adult patients with acquired haemophilia caused by antibodies to Factor VIII (FVIII), a rare and potentially life-threatening acute bleeding disorder.
OBIZUR is the first recombinant porcine sequence FVIII treatment available in Europe to treat acquired haemophilia A, and is designed to enable physicians to monitor treatment response by measuring FVIII activity levels in addition to clinical assessments. The approval is supported by results of a global, multi-centre Phase II/III trial in which all patients treated with OBIZUR (28/28) showed a positive response (bleeding stopped or reduced) and clinical improvement, with FVIII activity levels at 20% or higher at 24 hours after initial infusion.
Successful control (resolution) of the initial bleeding episode was observed in 86% (24/28) of all patients and in 94% (16/17) of those treated with OBIZUR as the first-line treatment. Acquired haemophilia A is a rare haemorrhagic disease in which autoantibodies against coagulation factor VIII, called FVIII-neutralizing antibodies (inhibitors), weaken the inherent coagulation system.
