Boehringer Ingelheim’s Antidote for Rapid Reversal of Dabigatran-Induced Anticoagulation Progresses into Next Stage of Clinical Investigation

Boehringer Ingelheim said its investigational antidote for the rapid reversal of Pradaxa-induced blood thinning has moved to the next step in its clinical development.

The product, idarucizumab, already has shown instant, complete and sustained reversal of the anticoagulant effect of dabigatran in 145 healthy volunteers, the company said. It will now be investigated in a clinical setting in patients taking BI’s blood thinner Pradaxa (dabigatran etexilate), marking the first time an antidote under development for a novel oral anticoagulant is investigated in a patient study, they noted.

The pivotal study is the last stage of clinical development and will show the potential of the specific antidote to support the treatment of patients taking Pradaxa, who may benefit from rapid reversal of dabigatran-induced anticoagulation, the company said.

Boehringer said emergency rooms in more than 35 countries will participate in the study. Doctors will be given idarucizumab as a “ready to use” solution for infusion.

“For those patients who do need reversal, the antidote would provide an additional option beyond the already existing measures in a physician’s toolbox,” said Charles Pollack, lead investigator of the patient study. “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.”

Because the antidote is still under investigation, it has not been approved for clinical use. The company said further safety and efficacy testing will be required prior to launch. — Kellen Owings

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