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Wyeth Announces FDA Approval of Recombinant Factor VIII Drug

Wyeth Announces FDA Approval of Recombinant Factor VIII Drug

Wyeth Pharmaceuticals announced that it received approval from the U.S. Food and Drug Administration for XYNTHA™ [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free], a recombinant factor VIII product, for patients with hemophilia A for the control and prevention of bleeding episodes and surgical prophylaxis. XYNTHA™ is manufactured without albumin, a soluble protein found in the blood that is sometimes used in the production of factor VIII (fVIII). XYNTHA™ undergoes a purification process without the use of human- or animal-based proteins such as monoclonal antibodies, which are often taken from mouse cell lines to make fVIII products.

“XYNTHA™ is important for hemophilia A patients because it establishes a new standard in recombinant factor VIII product purification technology,” says Robert R. Ruffolo, Jr., PhD, President, Wyeth Research, and Senior Vice President, Wyeth.

The safety and efficacy of XYNTHA™ were established through clinical trials. Side effects included hypersensitivity reactions, such as hives, wheezing and anaphylaxis. The company says that trace amounts of hamster protein used in the processing of the drug could contribute to allergic reactions. Of the 89 patients in the trial who completed 50 exposure days of the product, two developed an inhibitor.

Source: Wyeth press release dated February 21, 2008