Physicians' Academy for Cardiovascular Education

First reversal agent for novel oral anticoagulant submitted for regulatory approval

Mar. 9, 2015 - news

Idarucizumab, a reversal agent for the anticoagulant effect of dabigatran, has been submitted for approval of marketing authorisation to the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA) and Health Canada.
The submissions to the EMA, FDA and Health Canada 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, which is an ongoing global Phase III patient study in which idarucizumab is evaluated in patients treated with dabigatran who are in need of emergency intervention, or experience an uncontrolled or life-threatening bleeding event.
The regulatory submissions for idarucizumab are the first for a specific reversal agent to a novel oral anticoagulant. Idarucizumab was granted Breakthrough Therapy Designation by the U.S. FDA. Boehringer Ingelheim pursues accelerated procedures with all three regulatory authorities.
Boehringer Ingelheim press release 3 February 2015