The U.S. Food and Drug Administration (FDA) recently granted full approval to the drug idarucizumab (Praxbind), the reversal agent for anticoagulant dabigatran (Pradaxa). Idarucizumab is the first specific reversal agent for a direct-acting oral anticoagulant and a new treatment option for emergencies, such as serious bleeding or surgical interventions requiring immediate anticoagulant reversal.

In October 2015, FDA granted idarucizumab accelerated approval with continued approval contingent on results of the Phase III RE-VERSE AD trial. The RE-VERSE AD trial, published in the New England Journal of Medicine last year, showed that idarucizumab instantly reversed dabigatran’s anticoagulant effect with no adverse safety events and a low rate of thrombotic events.

Keywords: ACC Publications, Cardiology Magazine, Antithrombins, Anticoagulants, United States Food and Drug Administration, Antibodies, Monoclonal, Humanized, Hemorrhage, Thrombosis

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