Boehringer Ingelheim commences new study of Pradaxa antidote

Boehringer Ingelheim has announced the commencement of a new study of an antidote for Pradaxa, its dabigatran etexilate-based anticoagulant.

Idarucizumab, the investigational antidote for rapid reversal of dabigatran-induced anticoagulation, is now entering its next stage of development, having already demonstrated immediate and sustained reversal of dabigatran's anticoagulant effect in healthy volunteers.

The compound will now be investigated in the clinical setting among patients taking Pradaxa, marking the first time that an antidote under development for a novel oral anticoagulant is investigated in a study in patients.

Emergency rooms in more than 35 countries worldwide will participate in this study, with the first sites in Europe having already been initiated. More locations and countries will follow during the course of the year.

Lead investigator Dr Charles Pollack, professor of emergency medicine at the University of Pennsylvania School of Medicine, said: "For those patients who do need reversal, the antidote would provide an additional option beyond the already existing measures in a physician's toolbox."

Pradaxa has been approved in more than 100 countries and has accrued more than two million patient-years of experience in all licensed indications globally.