Boehringer’s BLA for idarucizumab gets FDA priority review

Idarucizumab is currently being investigated to specifically reverse the anticoagulant effect of dabigatran, the active ingredient in Pradaxa (dabigatran etexilate mesylate) in patients needing emergency intervention or experiencing an uncontrolled or life-threatening bleeding event.

The BLA will be reviewed under accelerated approval and is the first review for a reversal agent in the novel oral anticoagulant (NOAC) class. The company said that no NOACs currently have an approved reversal agent.

Boehringer Ingelheim Pharmaceuticals Medicine & Regulatory Affairs senior vice-president Sabine Luik said: "The FDA’s decision to grant Priority Review to the idarucizumab application is an important milestone and a step toward bringing a new innovative option in anticoagulation care to physicians and patients.

"If approved, idarucizumab has the potential to be a significant evolution in care by providing physicians with an option for PRADAXA patients in rare emergency situations that may require rapid reversal of the anticoagulation effect of dabigatran."

The BLA includes Phase I data showing the potential for idarucizumab to provide immediate reversal of the anticoagulant effect of dabigatran, the active ingredient in PRADAXA.

The company said that no clinically relevant adverse reactions to idarucizumab were observed in these trials.

In addition, no procoagulant effect was observed after the administration of idarucizumab when measured by coagulation assay.

Interim data from the ongoing RE-VERSE AD trial, a Phase III global trial investigating idarucizumab in actual clinical settings, was also included in the application.