The submission was based on a Phase 2/3 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 median annualized bleeding rate (ABR) was 2.0 (0.0 for spontaneous bleeds and joint bleeds). Nine patients in the study (39.1%) experienced no bleeds and 23 patients (88.5%) were treated with 1–2 infusions. In hemostatic efficacy, Rixubis was rated excellent or good at resolving bleeds in 96% of all episodes. Two (n=2) of the 26 bleeds seen in the trial were spontaneous.
Rixubis is a recombinant factor IX (rFIX) protein already approved for hemophilia B for both routine prophylaxis and control of bleeding episodes.
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