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Last Updated: Jun 30, 2008 - 11:14:37 AM |
THURSDAY FEB 21, 2008 (foodconsumer.org) -- The FDA issued a statement today saying that it had licensed a treatment fro hemophilia A, a rare hereditary blood clotting disorder that affects about 15,000 people, almost exclusively males in the United States.
Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free is a genetically engineered version of factor VIII, a protein that is essential for the blood clotting and is missing or reduced in patients with hemophilia A.
Xyntha made by Wyeth Pharmaceuticals Inc., is approved for the control and prevention of bleeding due to whatever causes including surgery in hemophilia A patients.
Factor VIII is made from modified genes from Chinese Hamster Ovary cells, which are free from known infectious agents. The drug undergoes an additional process to deactivate any virus. The cells are grown on a culture free of any human or animal material.
Clinical trials showed Xyntha was effective at preventing or controlling bleeding including preventing bleeding in patients with hemophilia A in surgery. Fever is the most common adverse reaction in patients who received surgery. Other side effects are mild or moderate in severity.
Another downside of this drug is that two of 80 patients who received 50 days of treatment with Xyntha developed inhibitors that counteract treatment with factor VIII.
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