BI 655075 filed with FDA as Antidote-Boehringer

Boehringer has submitted a biologics license application (BLA) to the FDA requesting an Accelerated Approval pathway, for the use of BI 655075 (idarucizumab) to reverse the anticoagulant effect of dabigatran, the active ingredient in Pradaxa (dabigatran etexilate mesylate). The new application includes phase I data in volunteers showing that idarucizumab provided immediate, complete and sustained reversal of the anticoagulant effect of dabigatran.

In these placebo-controlled studies, idarucizumab did not cause any clinically relevant side effects. No pro-thrombotic effect was observed after the administration of idarucizumab and no return of anticoagulant activity of dabigatran was seen over time at adequate doses. Other phase I data in healthy volunteers show that idarucizumab restores wound-site formation of fibrin, the main component of a blood clot.

Comment: Boehringer is continuing to evaluate idarucizumab in RE-VERSE AD, a phase III global study investigating idarucizumab in actual clinical settings. This is the only trial to examine patients being treated with Pradaxa who are in need of emergency intervention or experience an uncontrolled or life-threatening bleeding event.