Baxter announced that the FDA has approved Feiba (anti-inhibitor coagulant complex [AICC]) for use as routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B who have developed inhibitors.

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Feiba is a hemostatic that restores the impaired thrombin generation of hemophilia patients with inhibitors. Feiba shortens the activated partial thromplastin time (aPTT) of plasma containing factor VIII inhibitor.

The approval is based on data from FEIBA PROOF, a Phase 3 study that demonstrated a 72% reduction in median annual bleed rate with Feiba prophylaxis compared to an on-demand treatment. In the intent-to-treat analysis, 3/17 (18%) adult patients in the prophylactic arm had no bleeding episodes.

Feiba is already approved to control spontaneous bleeding or to cover surgical interventions in Hemophilia A and B with inhibitors.

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