The US Food and Drug Administration has granted breakthrough therapy designation to Boehringer Ingelheim’s antidote to its blockbuster bloodthinner Pradaxa.

Idarucizumab is a fully humanised antibody fragment designed specifically to reverse the anticoagulant effects of Pradaxa (dabigatran etexilate mesylate). Data from a Phase I study have shown the drug is able to achieve “immediate, complete and sustained reversal of dabigatran-induced anticoagulation in healthy humans”, BI stated. The German group is now conducting a Phase III trial is underway in patients taking Pradaxa who have uncontrolled bleeding or require emergency surgery or procedures.

For more details, go to: http://www.pharmatimes.com/Article/14-06-27/Breakthrough_status_for_BI_s_Pradaxa_antidote.aspx