FDA Grants Priority Review to Boehringer Ingelheim's BLA for Idarucizumab

Boehringer Ingelheim Pharmaceuticals has announced that the FDA has granted Priority Review to the Biologics License Application (BLA) for idarucizumab, which is 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 idarucizumab BLA will be reviewed under Accelerated Approval and is the first review for a reversal agent in the novel oral anticoagulant (NOAC) class. Currently, no NOACs have an approved reversal agent.

"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," said Sabine Luik, 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 for Pradaxa patients in rare emergency situations that may require rapid reversal of the anticoagulation effect of dabigatran."

The application includes Phase I data showing the potential for idarucizumab to provide immediate reversal of the anticoagulant effect of dabigatran, the active ingredient in Pradaxa. In these studies, no clinically relevant adverse events related to idarucizumab were observed. Additionally, 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 study investigating idarucizumab in actual clinical settings, was also included in the application.