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The FDA has granted Breakthrough Therapy designation to idarucizumab (Boehringer Ingelheim), an investigational fully humanized antibody fragment (Fab), being evaluated as a specific antidote for Pradaxa (dabigatran etexilate mesylate).

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

Boehringer Ingelheim announced that the Pradaxa (dabigatran etexilate mesylate capsules) prescribing information has been updated to affirm that Pradaxa 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin