Baxter announced that the Food and Drug Administration (FDA) has approved Rixubis (coagulation factor IX [recombinant]) for routine prophylaxis, control, and prevention of bleeding episodes, and perioperative management in children with hemophilia B.

The new approval was based on results of a clinical trial studying the efficacy and safety of Rixubis in 23 previously-treated male patients <12 years old with severe or moderately severe hemophilia B. The median annualized bleeding rate (ABR) was 2.0 (0.0 for spontaneous bleeds and joint bleeds). In the study, 9 patients (39.1%) experienced no bleeds.

RELATED: Baxter Seeks Approval of Ruxubis in Pediatric Hemophilia B Patients

Rixubis is an antihemophilic factor already approved for the prevention and control of bleeding in hemophilia B, perioperative management in hemophilia B, and for routine prophylaxis to prevent or reduce the frequency of bleeding in hemophilia B in adults.

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