Phase III RE-VERSE AD study of BI 655075 (idarucizumab) meets endpoint as antidote-Boehringer

Results from an interim analysis of the Phase III RE-VERSE AD patient study demonstrate that 5 g of BI 655075 (idarucizumab), from Boehringer, immediately reversed the anticoagulant effect of Pradaxa (dabigatran) in patients requiring urgent anticoagulant reversal. No safety concerns relating to idarucizumab were identified. The interim analysis from RE-VERSE AD included data from 90 patients in emergency settings who were taking dabigatran and required reversal.

Of the 81 patients that presented with elevated anticoagulation levels at baseline as measured with ECT, results showed the study met its primary endpoint, achieving 100 per cent maximum reversal as median value across all patients. Reversal was evident immediately after administration of the first vial of idarucizumab and was complete in all but 1 patient. After 4 and 12 hours, laboratory tests showed normal coagulation levels in almost 90 per cent of patients. Normal blood clotting (haemostasis) during surgery was reported in 92 per cent of the patients that required surgery or invasive procedures. There was no signal of a pro-coagulant effect following administration of idarucizumab.

Thrombotic events occurred in five patients, none of whom were receiving antithrombotic therapy at the time of the event. Finally there were 18 deaths overall - mortality within 96 hours of study enrolment appeared to be related to the original reason for emergency admission to the hospital, while all later events appeared to be related to co-morbidities.

The results have been simultaneously published in the New England Journal of Medicine (NEJM) and presented at the International Society of Thrombosis and Haemostasis 2015 Congress. See: "Idarucizumab for Dabigatran Reversal" Charles V. Pollack et al. New England Journal of Medicine, June 22, 2015 DOI 10.1056/NEJMoa1502000