While we anticipate that PRAXBIND will be rarely used in clinical practice, the availability of a specific reversal agent has the potential to give physicians and patients added assurance in choosing PRADAXA.' 'With this approval, Boehringer Ingelheim is again leading the evolution of anticoagulation care, as we did with the introduction of PRADAXA. 'We are very pleased to offer PRAXBIND, the first specific reversal agent for a novel oral anticoagulant, now approved by the FDA,' said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. Continued approval for this indication may be contingent upon the results of an ongoing cohort case series study. This indication is approved under accelerated approval based on a reduction in unbound dabigatran and normalization of coagulation parameters in healthy volunteers. PRAXBIND is indicated for patients treated with Pradaxa® (dabigatran etexilate mesylate), 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) granted approval of Praxbind® (idarucizumab). 16, 2015 /PRNewswire/ - Boehringer Ingelheim Pharmaceuticals, Inc.

Praxbind indication