Boehringer Ingelheim has announced it has submitted a biologics license application to the US Food and Drug Administration (FDA), requesting an Accelerated Approval pathway, for the use of idarucizumab to reverse the anticoagulant effect of dabigatran, the active ingredient in Pradaxa.
The new application includes phase I data in volunteers showing that idarucizumab provided immediate, complete and sustained reversal of the anticoagulant effect of dabigatran.
“The submission of this biologics license application just eight months after receiving Breakthrough Therapy Designation from the FDA provides further evidence of our commitment to delivering on patient and healthcare provider needs,” says Sabine Luik, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals. “If idarucizumab is approved, Pradaxa would be the first and only novel oral anticoagulant with a specifically targeted reversal agent.”
Boehringer Ingelheim announced that it 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.
Idarucizumab is a humanised antibody fragment, or Fab, being investigated as a specific reversal agent for the anticoagulant effect of dabigatran. Pre-clinical studies indicate idarucizumab binds specifically to and inhibits dabigatran.
Phase I data in healthy volunteers demonstrated the potential of idarucizumab to achieve immediate, complete and sustained reversal of dabigatran-induced anticoagulation. 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.
In June, the FDA granted Breakthrough Therapy Designation to idarucizumab.