Baxter announced positive results from a Phase 3 trial evaluating BAX 817 for the treatment of patients with hemophilia A or B who develop inhibitors.

The prospective, open-label, randomized, multi-center trial studied the safety and efficacy of BAX 817 in males aged 12–65 with hemophilia A or B with inhibitors for a 6-month period using on-demand therapy. The primary endpoint of successful resolution of acute bleeding episodes at 12 hours was met with both on-demand treatment regimens (3x90mcg/kg or 1x270mcg/kg) at an overall rate of 92%. Also, 89% of patients achieved sustained bleeding control for all acute bleeding episodes 24 hours post-infusion. None of the patients developed inhibitors or binding antibodies to BAX 817, and none discontinued treatment due to an adverse event.

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BAX 817 is an investigational recombinant factor VIIa (rFVIIa). Full study data with additional efficacy and safety outcomes will be presented at a medical meeting later in 2015.

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