Antidote for rapid reversal of Pradaxa® (dabigatran etexilate) progresses into next stage of clinical investigation with study in patients

Boehringer Ingelheim announced today that the multinational RE-VERSE AD clinical trial – the study investigating the emergency reversal of the anticoagulant effect of dabigatran – has been initiated in the UK.

The trial involves a number of sites in the UK and is part of the next step in the clinical development of idarucizumab,¹ the investigational antidote for rapid reversal of dabigatran-induced anticoagulation.

Idarucizumab has demonstrated immediate, complete and sustained reversal of the anticoagulant effect of dabigatran in a 145 participant healthy volunteer study.¹ Now, the antidote will be investigated in the clinical setting in patients taking Pradaxa® (dabigatran etexilate).² This is the first time that an antidote under development for a novel oral anticoagulant is investigated in a study in patients.²

The study will provide further knowledge on the potential of the specific antidote to support the management of patients taking Pradaxa® who may benefit from rapid reversal of dabigatran-induced anticoagulation.²

Emergency departments in more than 35 countries worldwide will participate in this study.² Participating sites will be equipped with the investigational antidote idarucizumab as a ‘ready to use’ solution for intravenous infusion. The first study sites in Europe have been initiated, and more sites and countries will follow during the course of the year.

Dr Charles De Wet, Medical Director UK and Ireland said,

“The safety and efficacy of dabigatran have been confirmed in several large-scale, multinational clinical studies.

Studies have also shown that without an antidote, patients who experienced major bleeding on dabigatran had a trend to lower mortality compared with those who had major bleeding on warfarin.

There are however rare occasions when an antidote might be beneficial as an additional management option in emergency situations.

For those patients who do need the anticoagulant effect of dabigatran reversed very quickly, this antidote would provide an additional option beyond those that already exist.”

The antidote is still under investigation, has not been approved for clinical use, and further safety and efficacy testing will be required prior to market launch.

1. Glund S, Strangier J, Schmohl M et al. Meeting Abstract 17765: A Specific Antidote for Dabigatran: Immediate, Complete and Sustained Reversal of Dabigatran Induced Anticoagulation in Healthy Male Volunteers. Circulation 2013; 128(22):Supplement.
2. RE-VERSE AD, Emergency reversal of the anticoagulant effects of dabigatran. Available at: http://clinicaltrials.gov/ct2/show/study/NCT02104947?show_locs=Y#locn. Last accessed: September 2014.