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CSL Behring’s Helixate®FS Receives FDA Approval for Prophylaxis in Children

CSL Behring announced that Helixate®FS, the company’s recombinant factor VIII product, has been approved by the U.S. Food and Drug Administration (FDA) for routine prophylaxis in children with hemophilia A. The approval is for children 16 years of age or younger who do not have “pre-existing” joint damage.

The FDA approval was based on a multicenter study of 65 boys who were younger than 30 months. Magnetic resonance imaging (MRI) of joints showed that prophylactic use of the factor product yielded less joint damage than did on-demand—7% vs. 42%. Joint damage occurred most frequently in the boys’ ankles.

“Bleeding into joints, including the ankles, elbows and knees, is a concern for children with hemophilia A and their treatment providers,” said Jerry S. Powell, MD, Director of the Hemophilia Treatment Center at the University of California, Davis. “The FDA's approval of Helixate FS for routine prophylaxis is an innovation that will help our patient population effectively manage their condition. Modern treatment of hemophilia means preventing bleeding through routine prophylaxis, and we eagerly anticipate our patients reaching young adulthood with minimal joint damage and the ability to pursue normal lives.”

Source: CSL Behring news release dated August 17, 2009