FDA Approves First-in-Class Therapy for Urgent Warfarin Reversal in Patients with Acute Major Bleeding

The U.S. Food and Drug Administration (FDA) announced  its approval of Kcentra (Prothrombin Complex Concentrate) on April 30. The drug, a first-in-class therapy, is used for urgent vitamin K antagonist (VKA) anticoagulation reversal in adult patients with acute major bleeding. The FDA approved Kcentra's orphan drug status in December 2012. Before Kcentra's approval, plasma was the only option for reversing warfarin and other VKA anticoagulants in the U.S.

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"The FDA's approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA anticoagulation," said Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research. "Kcentra is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse VKA anticoagulation."

The Agency approved the drug based on the results of a randomized, controlled Phase IIIb study that included 212 patients. "The pivotal clinical trial showed that Kcentra met all efficacy and safety endpoints, including the endpoints of hemostatic efficacy and International Normalized Ratio (INR) reduction compared with plasma, the most widely used agent for warfarin reversal in the United States," noted the drug's manufacturer, CSL Behring.

While Kcentra is shown to reverse the effects of warfarin, it does not work on the thrombin inhibitor dabigatran or any of the Factor Xa inhibitors rivaroxaban or apixiaban, the newest anticoagulants on the market.

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Keywords: Vitamin K, Thrombin, Orphan Drug Production, Morpholines, United States Food and Drug Administration, Benzimidazoles, Prothrombin, Factor Xa, Blood Coagulation Factors

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