Hemophilia Drug Approved by FDA

By Alice Turner
23:37, February 21st 2008
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Hemophilia Drug Approved by FDA

The US Food and Drug Administration cleared a drug for the treatment of hemophilia, a hereditary genetic disorder that impairs the body's ability to control blood clotting, or coagulation. More precisely, Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free, made by Wyeth Pharmaceuticals, targets patients who suffer from Hemophilia type A, which is caused by a mutation of the factor VIII gene, which leads to the absence of clotting factor VIII from the bloodstream.

Wyeth's Xyntha drug is a genetically engineered version of the factor VIII, a protein that causes blood to clot. It is made using cells extracted from hamster ovaries.

Hemophilia occurs nearly exclusively in men, and around 15,000 Americans suffer from the disorder, which causes severe bleeding when injuries occur. Statistically, 1 in 5,000 males are affected.

The FDA has also cleared the use of Xyntha in surgical patients.

"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," said Jesse Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research.



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