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FDA approves Xyntha for Hemophilia A

2/22/2008

WASHINGTON The Food and Drug Administration has recently approved Xyntha, a new drug for the treatment of Hemophilia A, a disorder that plagues about 15,000 people in the United States.

Xyntha, also known as Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free, is manufactured by Wyeth Pharmaceuticals Inc. According to published reports, Wyeth Pharmaceuticals creates advances in treatments for disorders by using special DNA techniques to create new DNA strands. This technique allows for the option to create such new things the body needs as a new protein.

For patients with Hemophilia A, a hereditary blood clotting disorder, the protein Factor VIII is either missing or is very low. Xyntha is an appropriate treatment for Hemophilia because it is the genetically engineered version of Factor VIII, which is essential for blood clotting.

Jesse Goodman, director of the FDA’s Center for Biologics Evaluation and Research commented on the approval by saying, “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.”

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