Boehringer Ingelheim start Phase III trial on idarucizumab as antidote to Pradaxa

German family-owned drug major Boehringer Ingelheim has initiated a global Phase III study on idarucizumab, in clinical settings where Pradaxa (dabigatran etexilate mesylate) patients may require emergency intervention or experience an uncontrolled or life-threatening bleed.

This is the first trial to investigate an antidote in patients actively being treated with a newer oral anticoagulant. Idarucizumab is being studied as a specific Pradaxa antidote.

Sabine Luik, senior vice president, medicine and regulatory affairs at Boehringer Ingelheim, said: “This trial is the next step in the development of idarucizumab, which began prior to regulatory approval of Pradaxa in 2010. While Pradaxa’s favorable risk-benefit profile has been well-established in clinical trials and reinforced through real-world analyses without an antidote, BI is committed to offering health care providers an additional therapeutic option to be considered should a patient require emergency intervention or if a patient experiences uncontrolled bleeding.”