Phase I study: Idarucizumab reverses anticoagulant effect of dabigatran in healthy volunteers

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that The Lancet published results from a phase I study investigating the effects of idarucizumab, an investigational agent, in reversing the anticoagulant effect of dabigatran in healthy volunteers. The data demonstrate that complete reversal was achieved following administration of idarucizumab. It was administered as either a single 5 minute infusion or as two five minute infusions given one hour apart. The reversal effect was sustained for more than 24 hours for all doses of 2g and above.

In this phase 1 study, 47 male volunteers aged 18-45 received 220 mg of dabigatran twice daily for three days, followed by a single dose on day four. Idarucizumab was administered approximately two hours after the final dabigatran dose, in doses of 1 g, 2 g, or 4 g as a five-minute infusion, or as two five-minute infusions of 5 g and 2.5 g one hour apart. The primary endpoint was incidence of drug-related adverse events, analyzed in all randomly assigned participants who received at least one dose of dabigatran. In this study, there were no clinically relevant idarucizumab-related adverse events. Results showed that idarucizumab immediately and completely reversed dabigatran-induced anticoagulation and no procoagulant effects were found when measured by a specific assay.

"These phase I results published in The Lancet add to the growing body of evidence supporting idarucizumab. We are committed to the continued study and development of this specifically targeted reversal agent," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "If approved, idarucizumab has the potential to be a significant evolution in care by providing physicians with an option to rapidly reverse the anticoagulant effect of dabigatran in rare emergency situations."

These data were initially presented at the American Heart Association's (AHA) Scientific Sessions 2013. Additional phase I data were presented at the AHA Scientific Sessions 2014 and the 2014 American Society for Hematology annual meeting (ASH).

In April 2015, the U.S. Food and Drug Administration granted priority review to Boehringer Ingelheim's Biologics License Application (BLA) for idarucizumab.