Baxter's Blood Disorder Drug Gets FDA Approval

By Reuters Staff

October 27, 2014

(Reuters) - Drugmaker Baxter International Inc said the U.S. Food and Drug Administration had approved its drug Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for treating bleeding episodes in adults with acquired hemophilia A(acquired Factor VIII deficiency).

On its website, the FDA notes that Obizur contains a recombinant analogue of porcine FVIII, which is "similar enough to human FVIII to be effective in blood clotting, but is less likely to be affected by the antibodies against human FVIII that are present in people with acquired hemophilia A."

The FDA site also points out that Obizur was tested in 29 adults with acquired hemophilia A and a serious bleeding episode. The trial demonstrated the effectiveness of Obizur in the treatment of bleeding episodes, with no safety concerns identified.

Obizur received orphan drug designation by the FDA. It will be launched in the United States in the coming months and is being reviewed by European and Canadian regulators, the company said.

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