1 The antidote was able to produce immediate, complete and sustained reversal of dabigatran induced anticoagulation. In the previous placebo-controlled healthy-volunteer study, the antidote was well tolerated and did not cause any clinically relevant side effects. "By supplying physicians more options to safely treat their patients, they are better equipped to confidently manage them knowing they are helping prevent debilitating strokes." Martina Flammer, Vice President, Medical and Drug Regulatory Affairs, Boehringer Ingelheim ( Canada) Ltd. "Commencing trials of idarucizumab* with patients taking Pradaxa® is the next step in providing physicians with a product of the highest possible standard to ensure patient safety," said Dr. Its safety and efficacy has not yet been fully established and it is currently not authorized for sale in Canada. * Idarucizumab is an investigational compound.
DABIGATRAN ANTIDOTE TRIAL
A pivotal trial is traditionally the last stage of clinical development before market authorization of a medication.Ī global phase III study, RE-VERSE AD™, is underway in patients taking Pradaxa® who have uncontrolled bleeding or require emergency surgery or procedures ( NCT02104947). 1,3 The pivotal study will provide knowledge on the potential of the specific antidote to support the treatment of patients taking Pradaxa®. 2 Boehringer Ingelheim is committed to the development of a Pradaxa®-specific antidote and to improving the standard of care by broadening the range of reversal options available to physicians. John Eikelboom, Associate Professor, Department of Medicine, McMaster University. "By removing the blood thinning effect of dabigatran in patients, physicians can focus on the other aspects of patient management and treatment."Īll blood thinning medications carry an increased risk of bleeding. "For patients who require rapid reversal of Pradaxa's anticoagulant effect, the antidote would provide physicians an additional option beyond their current management strategies," says Dr. This is the first antidote to be used to reverse the effects of a new anticoagulant for patients in an emergency situation due to bleeding.
1 Now the antidote will be investigated in the clinical setting in patients taking Pradaxa®.
The specific antidote has already demonstrated immediate, complete and sustained reversal of the anticoagulant effect of dabigatran in healthy volunteers. 22, 2014 /CNW/ - Today Boehringer Ingelheim announces the next phase in the clinical development program of the investigational antidote idarucizumab* for rapid reversal of Pradaxa® - induced anticoagulation. Antidote (idarucizumab)* already shown to provide immediate, complete and sustained reversal of anticoagulant effects of dabigatran in healthy adults 1īURLINGTON, ON, Sept.
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