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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
October 10, 2008

Media Inquiries:
Karen Riley, 301-827-6244
Consumer Inquiries:
888-INFO-FDA


FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A

The U.S. Food and Drug Administration today approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia.

Hemophilia A is a rare, hereditary, bleeding disorder in which a protein needed to form blood clots, factor VIII, is missing or its level is reduced. The disorder affects about 15,000 individuals in the United States, nearly all of whom are male.

"Administering Kogenate FS to children with hemophilia A with no pre-existing joint damage, every other day, will reduce bleeding into joints and help prevent joint damage, a major cause of disability in hemophiliacs," said Jesse Goodman, M.D., M.P.H., director, FDA’s Center for Biologics Evaluation and Research.

When individuals with hemophilia are injured, they bleed longer than a person without hemophilia. As a result, these individuals may experience serious bleeding episodes, often in the joints and muscles. Repeated bleedings increase the chance of joint damage.

Kogenate FS is a genetically engineered version of factor VIII. It was first licensed in the United States in 1993 for use during surgery and to prevent or control other bleeding episodes.

In a clinical trial, 65 boys under 30 months of age with severe hemophilia A and normal joints were observed for five years. The patients received either one daily dose of the drug, or three doses at the time of a bleeding episode. Joint damage during a bleeding episode was 6-fold lower, and the rate of bleeding 8-fold lower, in those boys who received the drug on a daily basis compared to those who received the drug only when a bleeding episode occurred. Most patients received the drug intravenously through a catheter.

The most common adverse events were infection at the catheter site and fever.

Kogenate FS is manufactured by Bayer Healthcare LLC, Tarrytown, N.Y.

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