Idarucizumab filed with EMA and Health Canada as Antidote for Dabigatran-Boehringer

Boehringer has submitted BI 655075 (idarucizumab) for approval of marketing authorisation to the European Medicines Agency (EMA) and Health Canada, for use in patients who require rapid reversal of the anticoagulant effect of dabigatran, the active ingredient in Pradaxa. This follows filing with the FDA. The submissions are based on the results from clinical trials of idarucizumab in volunteers, including elderly and renally impaired individuals. Phase I data showed an immediate, complete and sustained reversal of the anticoagulant effect of dabigatran following the administration of idarucizumab and no pro-thrombotic effect. The submissions also include first interim data from the ongoing RE-VERSE ADTM study. RE-VERSE ADTM is an ongoing global Phase III patient study in which Boehringer Ingelheim continues to evaluate idarucizumab in patients treated with Pradaxa who are in need of emergency intervention, or experience an uncontrolled or life-threatening bleeding event.