Baxter Receives FDA Approval for Orphan Drug ObizurBy
Baxter International Inc. has received US Food and Drug Administration (FDA) approval for Obizur (antihemophilic factor [recombinant] porcine sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (AHA), a rare and potentially life-threatening acute bleeding disorder. Obizur was granted orphan-drug status by the FDA and its review was prioritized based on AHA’s classification as a rare disease and the potential for the treatment to address an important unmet medical need.
Baxter says Obizur is the first recombinant porcine FVIII treatment approved for AHA that allows physicians to manage the treatment’s efficacy and safety by measuring factor VIII activity levels in addition to clinical assessments. It replaces the inhibited human factor VIII with a recombinant porcine sequence factor VIII based on the rationale that it is less susceptible to inactivation by circulating human factor VIII antibodies.
Obizur will be commercially available in the United States in the coming months and is currently under regulatory review in Europe and Canada.
Source: Baxter International