Boehringer Ingelheim submits applications for approval of idarucizumab*, specific reversal agent to dabigatran etexilate (Pradaxa®), to EMA, FDA and Health Canada
- First submission of an investigational specific reversal agent to a novel oral anticoagulant (NOAC) for regulatory approval
- Boehringer Ingelheim pursues accelerated procedures with all three authorities[1]
- In Phase I, idarucizumab has shown immediate, complete and sustained reversal of the anticoagulant effect of dabigatran (Pradaxa®)[2]
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 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.[5]
* Idarucizumab is the recommended International Nonproprietary Name (INN).
Idarucizumab is in late-stage development and has not yet been approved for clinical use.
Please click on the link below for ‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/03_march_2015_dabigatranetexilate.html
Website: http://www.boehringer-ingelheim.com
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This news is a press release provided by Boehringer Ingelheim International GmbH.
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2021년 9월 10일 15:15
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2021년 3월 2일 15:05