Antidote for rapid reversal of Pradaxa® (dabigatran etexilate) progresses into next stage of clinical investigation with study in patients
On May 22, 2014, Boehringer Ingelheim announced the next step in the clinical development of idarucizumab, an investigational antidote for rapid reversal of dabigatran-induced anticoagulation. Prior clinical research of the antidote in a healthy volunteer study with 145 participants has already demonstrated its potential for immediate, complete and sustained reversal of the anticoagulant effect of dabigatran. No pro-thrombotic effect was observed after the administration of the antidote, and no return of anticoagulant activity of dabigatran over time was found at adequate doses.
Idarucizumab will now be investigated in the clinical setting in patients taking Pradaxa® (dabigatran etexilate). Emergency rooms in more than 35 countries worldwide will participate in this study. Physicians will be equipped with the investigational antidote idarucizumab as a ‘ready to use’ solution for infusion. The first study sites in Europe have been initiated, and more sites and countries will follow during the course of the year.
“For those patients who do need reversal, the antidote would provide an additional option beyond the already existing measures in a physician’s toolbox. The antidote would remove the anticoagulant effect of dabigatran from the clinical scenario so that physicians can focus on the other aspects of patient management,” said Dr. Charles Pollack, Professor of Emergency Medicine at the University of Pennsylvania School of Medicine and Chairman of Emergency Medicine at Pennsylvania Hospital in Philadelphia, USA and lead investigator of the patient study.
The antidote is still under investigation, has not been approved for clinical use, and further safety and efficacy testing will be required prior to market launch.
Source: Boehringer Ingelheim press release [Link]