Boehringer Ingelheim submits applications for approval of idarucizumab to EMA, FDA and Health Canada

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.

References

1. Boehringer Ingelheim Data on File.
2. Glund S, et al. A specific antidote for dabigatran: immediate, complete and sustained reversal of dabigatran induced anticoagulation in healthy male volunteers. American Heart Association Scientific Sessions, Dallas, TX, USA, 16-20 November 2013, abstract 17765.
3. Boehringer Ingelheim Press Release – 30 June 2014. U.S. FDA grants Breakthrough Therapy Designation to Pradaxa® (dabigatran etexilate) specific investigational antidote. http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/30_june_2014_dabigatranetexilate.html
   Last accessed March 2015.
4. Glund S. et al. Idarucizumab, a Specific Antidote for Dabigatran: Immediate, Complete and Sustained Reversal of Dabigatran Induced Anticoagulation in Elderly and Renally Impaired Subjects. Presented on 8th December at the 56th American Society of Hematology Annual Meeting & Exposition, San Francisco, USA. Available at: https://ash.confex.com/ash/2014/webprogram/Paper74960.html Last accessed March 2015.
5. Pollack C, et al. A Phase III Clinical Trial to Evaluate the Reversal Effects of Idarucizumab on Active Dabigatran (RE-VERSE AD™). International Stroke Conference, Nashville, TN, USA, 11-13 February 2015, Poster presentation.