In late February 2008, the US Food and Drug Administration (FDA) approved Xyntha™, a new treatment for hemophilia A. Manufactured by Wyeth, Xyntha joins the field previously occupied exclusively by Baxter’s Advate®, giving a choice of third-generation plasma-free and albumin-free recombinant factor products to people with hemophilia A.
According to the FDA, studies show that Xyntha and Advate are equal in absorption, distribution, metabolism and elimination of the drugs in the body.
“This product [Xyntha] 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,” says Jesse Goodman, MD, MPH, director of the FDA’s Center for Biologics Evaluation and Research.
Xyntha is produced using the same molecule as ReFacto®, Wyeth’s current hemophilia A product, but with a new, purer formulation process that is safer and eliminates almost all human and animal proteins. It is the only recombinant factor VIII product using a nonhuman/nonanimal purification process. ReFacto continues to be available to consumers.
In clinical trials, Xyntha was shown to be effective at preventing or controlling bleeding, including bleeding in surgery, for people with hemophilia A. Generally, the most frequently reported adverse reactions were headache and fever. Most adverse reactions reported in either study were considered mild or moderate in severity.
Two of the 89 people who received 50 exposure days of treatment with Xyntha developed factor VIII inhibitors.
Xyntha will be sold beginning in July 2008 in the following quantities: 250, 500, 1,000 and 2,000 IU/vial fill sizes. Pricing information is not yet available.