Wyeth has won FDA approval Xyntha, a treatment for patients with hemophilia A, a rare blood-clotting disorder in which sufferers lack a key protein (Factor VIII) that prevents excessive bleeding. Xyntha is a genetically engineered version of the missing blood protein that's essential for clotting. "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, director of FDA's CBER. The product is entirely synthetic; previous treatments for the disease used monoclonal antibodies derived from mouse cell lines. About 15,000 people in the U.S. suffer from the disease.
- check out the release
- and here's the FDA's statement on the approval