Wednesday, August 19, 2009

Helixate FS Receives FDA Approval for Routine Prophylaxis in Children with Hemophilia A

CSL Behring announced today thatHelixate® FS, Antihemophilic Factor (Recombinant), has been approved by the U.S. Food and Drug Administration (FDA) for routine prophylaxis in children with hemophilia A who are 16 years old or younger and do not have pre-existing joint damage. This new indication was granted by the FDA after determining Helixate FS is safe and effective for routine prophylaxis, which can reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A.
“The FDA's approval of this additional indication for Helixate FS will significantly benefit the bleeding disorders community,” said Garrett E. Bergman, M.D. Senior Director of Medical Affairs, U.S. Commercial Operations at CSL Behring. “Prophylactic treatment will reduce the frequency of bleeding episodes in children with hemophilia A which, over time, will help prevent additional joint damage caused by bleeds.”
"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, M.D., 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."
With more than 2.5 billion units infused to date, Helixate FS has been shown to be safe and effective in clinical studies as well as in post marketing use in the hemophilia community. For more information about Helixate FS, please visit or call CSL Behring Consumer Affairs at 1-888-508-6978

No comments: