Reversal was complete and sustained for a minimum of 12 hours in almost all patients. In the studies, the reversal effects of idarucizumab were evident immediately, within minutes after administration of 5 grams of idarucizumab.

Idarucizumab was approved by the US Food and Drug Administration in October 2015.Īccording to Boehringer Ingelheim, the approval is based on data from healthy volunteers, as well as results from an interim analysis of the RE-VERSE AD clinical study. The approval of idarucizumab by the European Commission follows the positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency in September 2015. Idarucizumab is the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant to be approved in the European Union, stated the company. November 26, 2015-Boehringer Ingelheim Pharmaceuticals announced that the European Commission has approved Praxbind (idarucizumab), a treatment to rapidly and specifically reverse the anticoagulant effects of the company’s Pradaxa (dabigatran etexilate) in cases of emergency surgery/urgent procedures or in situations of life-threatening or uncontrolled bleeding.

Pradaxa praxbind