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FDA Expands Labeling for Rixubis (Coagulation Factor IX [Recombinant]) to Include Children With Hemophilia B
The FDA has approved Rixubis (coagulation factor IX [recombinant], Baxter) for routine prophylactic treatment, control, and prevention of bleeding episodes and for perioperative management in children with hemophilia B.
Rixubis was the first recombinant factor IX to be approved for routine prophylaxis and control of bleeding episodes in the U.S. for adults with this chronic condition.
The new approval was based on the results of a clinical trial investigating the efficacy and safety of Rixubis in 23 previously treated male patients less than 12 years of age with severe or moderately severe hemophilia B. The patients were treated with a twice-weekly Rixubis prophylaxis regimen (mean dose: 56 IU/kg) for a mean treatment period of 6 months and a mean of 54 exposure days (EDs).
The median annualized bleeding rate was 2.0 (0.0 for spontaneous bleeds and joint bleeds). Nine patients in the study (39%) experienced no bleeds, and 23 bleeding episodes (89%) were treated with one or two infusions. There were no reports of the development of inhibitors, no severe allergic reactions, and no thrombotic or treatment-related adverse events (AEs). The most common AEs (observed in more than 1% of subjects) in clinical studies included dysgeusia, pain in an extremity, and a positive test for furin antibody.
Rixubis (coagulation factor IX [recombinant]) is an antihemophilic factor indicated for adults and children with hemophilia B for the control and prevention of bleeding episodes, perioperative management, and routine prophylaxis. Rixubis is not indicated for the induction of immune tolerance in patients with hemophilia B.
Source: Baxter; September 15, 2014.