FDA Approves New Hemophilia Treatment

February 21, 2008

The U.S. Food and Drug Administration announced this week that it has approved a new treatment for hemophilia A, a rare, hereditary, blood-clotting disorder that mostly affects males.

THURSDAY, Feb. 21 (HealthDay News) -- The U.S. Food and Drug Administration announced this week that it has approved a new treatment for hemophilia A, a rare, hereditary, blood-clotting disorder that mostly affects males.

Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free is a genetically engineered version of factor VIII, the blood clotting protein that is absent or decreased in patients with hemophilia A. The FDA has licensed Xyntha for prevention or control of bleeding in patients with hemophilia A, including bleeding as a result of accident or injury, or during surgery.

Xyntha, which is manufactured by Wyeth Pharmaceuticals, is produced by modifying Chinese hamster ovary cells to produce factor VIII in a process free of known infectious agents. In clinical trials, Xyntha was shown to be effective in preventing or controlling bleeding in patients with hemophilia A, and was generally well tolerated, with the most commonly reported side effect of headache. Furthermore, only two of 89 patients treated for 50 days with Xyntha developed antibodies against factor VIII.

"This product provides an additional treatment option for hemophilia A patients. This recombinant factor VIII is produced without additives from human or animal material, which further minimizes any risk of infection from the product," explains Jesse Goodman, M.D., director of FDA's Center for Biologics Evaluation and Research.

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