FDA Breakthrough status for Boehringer’s investigational Pradaxa antidote

The US Food and Drug Administration has granted Breakthrough Therapy designation to idarucizumab, an investigational fully-humanized antibody fragment, or Fab, being studied as a specific antidote to reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate), by German family-owned drug major Boehringer Ingelheim.

Sabine Luik, senior vice president, medicine and regulatory affairs, at Boehringer Ingelheim Pharmaceuticals Inc, stated: "We are committed to innovative research and to advancing care in patients taking Pradaxa. We continue to investigate the potential of idarucizumab as a therapeutic option should a patient experience uncontrolled bleeding or need to undergo emergency surgery or another invasive procedure."

Plans to pursue an accelerated approval pathway