Boehringer Ingelheim submits applications for approval of idarucizumab*, specific reversal agent to dabigatran etexilate (Pradaxa®), to EMA, FDA and Health Canada

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Boehringer Ingelheim today announces that idarucizumab has been submitted for approval of marketing authorisation to the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA) and Health Canada.¹ 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 U.S. FDA.³ 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.^1,2,4 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.² The submissions also include first interim data from the ongoing RE-VERSE AD^TM study. RE-VERSE AD^TM 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.⁵

* Idarucizumab is the recommended International Nonproprietary Name (INN).
Idarucizumab is in late-stage development and has not yet been approved for clinical use.

~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/03_march_2015_dabigatranetexilate.html

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