Baxter announced that the Food and Drug Administration (FDA) has approved Obizur (antihemophilic factor [recombinant], porcine sequence) for the treatment of bleeding episodes in adults with acquired hemophilia A.
Obizur is the first recombinant porcine factor VIII (FVIII) treatment approved for hemophilia A that allows healthcare professionals to manage treatment efficacy by measuring FVIII levels in addition to other clinical tests. The recombinant porcine sequence factor VIII is presumed to be less susceptible to inactivation by the circulating human factor VIII antibodies.
The FDA approval was based on a Phase 2/3 global, prospective, controlled, multicenter, open-label trial that studied the efficacy of Obizur in the treatment of serious bleeding episodes in adults with hemophilia A (n=28). All patients treated with Obizur demonstrated a positive response, defined as an effective or partially effective response with bleeding stopped or reduced and clinical improvement at 24 hours after the initial infusion. A total of 86% had successful treatment of the initial bleeding episode.
Obizur was previously granted orphan drug status and priority review. Obizur will be available as 500 unit single-use vials in 1-, 5-, and 10-count packages. It is expected to launch in the coming months.
For more information call (800) 422-9837 or visit Baxter.com.