NAPSR News: FDA Greenlights Baxter's OBIZUR for Acquired Hemophilia A

“The approval of this product provides an important therapeutic option for use in the care of patients with this rare disease,” said Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research.
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WASHINGTON - Oct. 27, 2014 - PRLog -- Baxter International, a global healthcare company with expertise in medical devices, pharmaceuticals and biotechnology has received approval from the United States Food and Drug Administration (FDA) for their new haemophilia therapy, OBIZUR. OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence] is specifically intended to treat adult patients with acquired hemophilia A (AHA) a rare bleeding disorder caused by an autoantibody to coagulation factor (F) VIII and is observed in patients with no genetic predisposition to bleeding. Bleeding varies from acute, life-threatening hemorrhage to mild bleeding. OBIZUR contains a recombinant analogue of porcine (pig) FVIII] due to its similarity to human FVIII to be effective in blood clotting and is less susceptible to inactivation by circulating human factor VIII antibodies.

"The approval of OBIZUR is welcome news for the hemophilia community based on the data from the first clinical trial designed specifically for acquired hemophilia A, which found that all patients responded to treatment within 24 hours," said Dr. Rebecca Kruse-Jarres, Director of the Hemophilia Care Program at Puget Sound Blood Center in Seattle and the clinical trial's principal investigator. "Importantly, this new option to treat bleeding episodes will enable us to measure factor VIII levels, thus giving us an objective marker of hemostasis that can guide dosing and prevent overdosing."

The FDA approval was based on Phase2/3 studies administered in a controlled, multi-center open-label clinical trial setting, analyzing the efficacy of OBIZUR in adult patients with AHA.  All 28 patients treated with OBIZUR indicated a positive response, either bleeding stopped or was significantly reduced at 24 hours after the initial infusion. Overall 86 percent (24/28) had successful treatment of the initial bleeding episode.

OBIZUR will be commercially available in the United States in a few a months and is currently under regulatory review in Europe and Canada.

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