Boehringer Ingelheim announced that the Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for idarucizumab, a humanized antibody fragment to reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate) in patients needing emergency intervention or experiencing an uncontrolled or life-threatening bleeding event.

The BLA submission was based on Phase 1 data showing the potential for idarucizumab to provide immediate reversal of the anticoagulant effect of dabigatran. A procoagulant effect was not observed after the administration of idarucizumab when measured by coagulation assay. Interim data from the ongoing RE-VERSE AD trial, a Phase 3 global study investigating idarucizumab in actual clinical settings, was also included in the application.

RELATED: BI Requesting Accelerated Approval for Pradaxa Reversal Agent

Pradaxa is approved to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation (AF); to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with parenteral anticoagulant for 5–10 days; and to reduce risk of recurrent DVT/PE in patients who have been previously treated.

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