In the RE-VERSE AD study, no serious adverse safety signals were observed, and thrombotic events occurred in 6.3% of patients who had uncontrolled bleeding with dabigatran and in 7.4% of patients who were about to undergo an urgent procedure.The U.S. The majority of patients had complete reversal of anticoagulation within four hours as measured by ecarin clotting time (ECT 82%) or diluted thrombin time (dTT 99%). The final results of RE-VERSE AD were published in the New England Journal of Medicine in July 2017 and showed that idarucizumab immediately reversed the anticoagulant effect of dabigatran.

The FDA granted accelerated approval to idarucizumab in October 2015, with continued approval contingent upon results from the phase III RE-VERSE AD trial, the largest study to investigate a reversal agent for a NOAC. “We believe that the wide availability of Praxbind - and the robust data on its use - can provide patients and health-care providers with greater assurance in their anticoagulation treatment decisions.” “In the rare event of an emergency situation requiring reversal, treatment decisions must be made quickly and confidently,” said Thomas Seck, MD, vice president of clinical development and medical affairs for Boehringer Ingelheim Pharmaceuticals Inc. Idarucizumab is indicated for patients treated with dabigatran when reversal of the anticoagulant’s effects is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding, the company said. Food and Drug Administration has granted full approval for idarucizumab (Praxbind), a reversal agent for the anticoagulant dabigatran etexilate mesylate (Pradaxa), Boehringer Ingelheim announced in a news release.

Praxbind fda approval