Boehringer Ingelheim, one of the world's 20 leading pharmaceutical companies, announces that idarucizumab has been submitted for approval of marketing authorisation to the European Medicines Agency (EMA), US Food and Drug Administration (FDA) and Health Canada. The submission is for use in patients who require rapid reversal of the anticoagulant effect of dabigatran, the active ingredient in Pradaxa.
“The submissions for idarucizumab mark the first regulatory submissions for a specific reversal agent to a novel oral anticoagulant,” said Professor Jörg Kreuzer, vice president Medicine Therapeutic Area Cardiovascular, Boehringer Ingelheim. “Our discovery and development of idarucizumab in-house is an example of our company’s dedication to the evolution and innovation of anticoagulation care. Idarucizumab is being developed to provide physicians with a specifically targeted reversal agent for Pradaxa patients in rare emergency situations.”
Idarucizumab was granted Breakthrough Therapy Designation by the US FDA. Boehringer Ingelheim pursues accelerated procedures with all three regulatory authorities.1
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. 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.