CSL Behring announced that Helixate FS, Antihemophilic Factor (Recombinant), has been approved by the US Food and Drug Administration (FDA) for routine prophylaxis in children with haemophilia 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 haemophilia A.

"The FDA's approval of this additional indication for Helixate FS will significantly benefit the bleeding disorders community," said Garrett E Bergman, senior director of Medical Affairs, US Commercial Operations at CSL Behring. "Prophylactic treatment will reduce the frequency of bleeding episodes in children with haemophilia 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 haemophilia A and their treatment providers," said Jerry S Powell, director of the Haemophilia 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 haemophilia 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 haemophilia community.

Helixate FS is a recombinant factor VIII product indicated to control and prevent bleeding episodes in adults and children with haemophilia A.

CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide.