Boehringer Ingelheim has submitted idarucizumab for marketing authorization to the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and Health Canada.The submission is for use in patients who require rapid reversal of the anticoagulant effect of dabigatran, the active ingredient in Pradaxa, an oral anticoagulant.

Idarucizumab was granted Breakthrough Therapy Designation by the FDA.

Source: Boehringer Ingelheim