FDA Approves New Hemophilia Treatment
Posted on: Thursday, 21 February 2008, 15:00 CST
The U.S. Food and Drug Administration approved a new treatment for hemophilia A -- a rare, hereditary blood-clotting disorder.
The FDA said the medical condition affects approximately 15,000 individuals, nearly all males, in the United States.
The new treatment, called Xyntha, or Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free, is a genetically engineered version of factor VIII -- a protein essential for blood clotting.
Factor VIII, known as an anti-hemophilic factor, is missing or decreased in patients with hemophilia A.
The FDA said it licensed Xyntha for the control and prevention of bleeding, which can occur spontaneously, after an accident or injury and from surgery in patients diagnosed with hemophilia A.
Xyntha is manufactured by Wyeth Pharmaceuticals Inc. using recombinant DNA techniques that enable scientists to create new DNA strands with specific traits, such as the capacity to produce a specific protein.
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 Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research.
Source: United Press International
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