THURSDAY, Feb. 21, 2008 (HealthDay News) -- The U.S. Food and Drug Administration has approved Xyntha, a genetically engineered version of a blood protein that's essential for clotting. In hemophiliacs, this protein, called factor VIII, is missing or its effectiveness is decreased.
Xyntha is licensed to control or prevent bleeding, which can occur among hemophiliacs during or after an injury, often spontaneously. Xyntha also is sanctioned to prevent bleeding during surgery among people with hemophilia A.
The rare disorder affects about 15,000 people in the United States, almost exclusively males, the FDA said in a prepared statement.
To make Xyntha, genes from Chinese hamster ovary cells are engineered to produce the protein that's missing in hemophiliacs. The cells are free from known germs and undergo a process designed to inactivate viruses.
Side effects reported during clinical testing included headache and fever, and most cases were considered mild to moderate, the FDA said. Two of the 89 people who underwent 50 days of treatment developed antibodies to Xyntha that countered the treatment's ability to work.
Xyntha is manufactured by Wyeth Pharmaceuticals.
More information
The FDA has more about this approval.
