First human data show promise of Boehringer’s specific antidote for Pradaxa-induced anticoagulation

Presented for the first time at the American Heart Association’s (AHA) Scientific Sessions, results from the first clinical study in healthy volunteers demonstrate the potential of an antibody fragment (Fab) as a specific antidote for immediate, complete and sustained reversal of dabigatran-induced anticoagulation.

German family-owned drug major Boehringer Ingelheim, the maker of Pradaxa (dabigatran), which generated sales of 612 million euros ($902.7 million) in the first half of 2013, says the development of the antidote is part of the company’s commitment to further broadening the range of reversal options available to physicians in rare critical care situations. The antibody fragment has not yet been approved for clinical use and is still undergoing investigation to further establish its efficacy and safety profile.

Bayer/J&J and Bristol-Myers/Pfizer also working on antidote