INGELHEIM, Germany - Tuesday, June 16th 2015 [ME NewsWire]
Specific reversal agent idarucizumab* led to immediate, complete and sustained reversal of Pradaxa® in healthy individuals
Complete reversal was achieved with a single five-minute infusion of idarucizumab which was well tolerated
Data now published are part of the ongoing regulatory review for approval of idarucizumab by the FDA, EMA and Health Canada
(BUSINESS WIRE)-- Today, The Lancet published results from a healthy volunteer study investigating the reversal of the anticoagulant effect of Pradaxa®(dabigatran etexilate) by its specific reversal agent idarucizumab. The study showed that idarucizumab led to immediate, complete and sustained reversal of the anticoagulant effect of Pradaxa®. The data support the specific reversal agent as a highly targeted treatment option if reversal of the anticoagulant effect is needed, e.g. for urgent interventions.1 Idarucizumab was granted Breakthrough Therapy Designation by the U.S. FDA2 and has recently been submitted for approval to the FDA, EMA and Health Canada.3 Boehringer Ingelheim pursues accelerated procedures with all three regulatory authorities.3
In the healthy volunteer study now published in The Lancet, participants first received Pradaxa® and then idarucizumab. The specific reversal agent was given two hours after the last dose of Pradaxa®, when dabigatran concentrations were at peak levels. After a five-minute infusion of idarucizumab, anticoagulation was immediately reversed back to baseline levels. The reversal effect was sustained for more than 24 hours for all doses of 2g and above. Idarucizumab was well tolerated by the study participants.1
“The data now published in The Lancet show in an impressive manner how effective idarucizumab was for reversing Pradaxa® in healthy volunteers”, said Professor Jörg Kreuzer, Vice President Medicine Therapeutic Area Cardiovascular, Boehringer Ingelheim. “Once approved, the availability of a specific reversal agent for a NOAC will be yet another landmark in anticoagulation care.”
Similar results were also seen in elderly and renally impaired volunteers in a study presented at the Annual Meeting & Exposition of the American Society for Hematology in December 2014.4 Boehringer Ingelheim is now evaluating idarucizumab in the RE-VERSE ADTM study, the first study to investigate a reversal agent to a non-vitamin K antagonist oral anticoagulant in patients.5
*Idarucizumab is the recommended International Nonproprietary Name (INN). Idarucizumab is an investigational drug, which has not been approved for clinical use, and further safety and efficacy testing will be required.
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Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/16_june_2015_dabigatranetexilate.html
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