In the RE-VERSE AD study, no adverse safety signals were observed and there was a low rate of thrombotic events. 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 Praxbind immediately reversed the anticoagulant effect of Pradaxa.
The FDA granted accelerated approval to Praxbind 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 healthcare 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, M.D., vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc.
Praxbind is indicated for patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. Food and Drug Administration (FDA) has provided full approval for Praxbind® (idarucizumab), the specific reversal agent for Pradaxa® (dabigatran etexilate mesylate). RIDGEFIELD, Conn., Ap/PRNewswire/ - Boehringer Ingelheim today announced that the U.S.
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