On September 12, 2014, the United States Food and Drug Administration (FDA) approved Baxter International Inc.’s RIXUBIS for routine prophylactic treatment, control and prevention of bleeding episodes, and perioperative management in children with hemophilia B.
RIXUBIS was the first recombinant factor IX or rFIX approved for routine prophylaxis and control of bleeding episodes in the U.S. for adults living with this chronic condition.
The approval is based on the results of a study investigating the efficacy and safety of RIXUBIS among 23 previously treated male patients less than 12 years of age with severe or moderately severe hemophilia B. Baxter’s application for marketing approval for RIXUBIS for adults and pediatric patients is currently under review in the European Union, with a regulatory decision expected later this year. Also, the treatment recently gained regulatory approval in Australia.