FDA Grants Full Approval Anticoagulant Reversal Agent

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 novel 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 in 2017, showed that idarucizumab instantly reversed dabigatran's anticoagulant effect with no adverse safety events and a low rate of thrombotic events.

Clinical Topics: Anticoagulation Management

Keywords: ACC Advocacy, Anticoagulants, Hemorrhage, Thrombosis

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