Baxter's Rixubis receives FDA nod

DEERFIELD, Ill. — Baxter International announced that the Food and Drug Adminsitration approved Rixubis [coagulation factor IX (recombinant)] for the treatment, control and prevention of bleeding episodes, as well as perioperative management, in children with hemophilia B. 

 

"In addition to the positive reception we’ve received from adult Rixubis patients, the approval for pediatric patients offers a valuable new option, particularly as our clinical data demonstrated a significant reduction in bleeding episodes for patients who were treated prophylactically, an important factor for this young patient population," said John Orloff, M.D., VP of global research and development at Baxter BioScience.

 

Rixubis was the first recombinant factor IX approved by the FDA for routine prophylaxis and control of bleeding episodes in the United States for adults, the company stated.