CSL Behring Receives FDA Approval For Helixate FS

CSL Behring has announced that Helixate FS, Antihemophilic Factor (Recombinant), has been approved by the FDA. It is for routine prophylaxis in children with hemophilia A who are 16 years old or younger and do not have pre-existing joint damage.

The new indication was granted by the FDA after determining that 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.

Garrett Bergman, senior director of medical affairs for US Commercial Operations at CSL Behring, said: “The FDA’s approval of this additional indication for Helixate FS will significantly benefit the bleeding disorders community. 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.”