Priority Review Granted for Pradaxa Reversal Agent

Priority Review Granted for Pradaxa Reversal Agent
Priority Review Granted for Pradaxa Reversal Agent

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.

For more information call (800) 542-6257 or visit Boehringer-Ingelheim.com.

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