Dabigatran antidote given green light by FDA

The first antidote for a novel oral anticoagulant (NOAC) has been approved by the Food and Drug and Drug Administration and is awaiting approval by the TGA.

Idarucizumab (Praxbind) is a monoclonal antibody that reverses the anticoagulant effect of dabigatran (Pradaxa) in patients who require emergency surgery or have life-threatening bleeding.

The reversal agent was fast-tracked to FDA approval after its safety and effectiveness were confirmed in a Phase III study published in the New England Journal of Medicine in June.