![]() The US Food and Drug Administration (FDA) has granted accelerated approval to Praxbind (idarucizumab. Praxbind (idarucizumab) is a humanized monoclonal antibody fragment (Fab) indicated in patients treated with Pradaxa® (dabigatran) when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding. For which conditions is this drug approved Praxbind is indicated for patients specifically treated with Pradaxa (dabigatran etexilate mesylate), an anti-. 'PRAXBIND was made available immediately following FDA approval in October 2015, and is now stocked in more than 2,760 hospital pharmacies in all fifty states,' said Sabine Luik, MD, senior vice. FDA Approves Praxbind to Reverse Anticoagulant Pradaxa. ![]() Treatment for: Reversal Agent for Pradaxa Last updated by Judith Stewart, BPharm on April 7, 2020.įDA Approved: Yes (First approved October 16, 2015)Ĭompany: Boehringer Ingelheim Pharmaceuticals, Inc. The FDA approval of Praxbind was based on a single cohort case series trial with dabigatran-treated patients who had life-threatening or uncontrolled. The FDA granted PRAXBIND Breakthrough Therapy Designation and the application received Priority Review.
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