FDA Approves First Novel Oral Anticoagulant Reversal Agent

The approval is the first of its kind for a reversal agent of a novel oral anticoagulant (NOAC).

Officials with the FDA today approved idarucizamub (Praxbind, Boehringer Ingelheim) for the reversal of the anticoagulant dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim) in patients in need of emergency surgery, urgent procedures, or facing life-threatening or uncontrolled bleeding.

The approval is the first of its kind for a reversal agent of a novel oral anticoagulant (NOAC).

"In the rare event of an emergency situation requiring reversal, treatment decisions must be made quickly and confidently," said Thomas Seck, MD, the vice president of Clinical Development and Medical Affairs at Boehringer Ingelheim Pharmaceuticals, Inc, in a statement. "We believe that the wide availability of Praxbind—and the robust data on its use—can provide patients and healthcare providers with greater assurance in their anticoagulation treatment decisions."

Dabigatran etexilate mesylate was approved in October 2015, based on data from the RE-VERSE AD phase 3 trial, which the FDA also utilized to evaluate its antidote. The trial included 503 patients worldwide at 173 sites, split into 2 groups: Group A (n = 301), in which 60% presented with uncontrolled or life-threatening bleeding, and Group B (n = 202), in which 40% required an invasive procedure or an emergency surgery or intervention.

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