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. Food and Drug Administration approved Praxbind as a specific reversal agent for Pradaxa in October 2015 under accelerated approvalfollowed by full approval in April 2018for use in. The FDA approval of Praxbind was based on a single cohort case series trial with dabigatran-treated patients who had life-threatening or uncontrolled bleeding, or who required emergency surgery or urgent procedure (RE-VERSE AD). Treatment for: Reversal Agent for Pradaxa The US Food and Drug Administration (FDA) today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant.

Last updated by Judith Stewart, BPharm on April 7, 2020.įDA Approved: Yes (First approved October 16, 2015)Ĭompany: Boehringer Ingelheim Pharmaceuticals, Inc.

Praxbind fda approval