The approval is based on data from healthy volunteers, as well as results from an interim analysis of the RE-VERSE AD clinical study. In the studies, the reversal effects of idarucizumab were evident immediately, within minutes after administration of 5 grams of idarucizumab. Reversal was complete and sustained for a minimum of 12 hours in almost all patients. Reversal effects of idarucizumab evident within minutes of administration in study “The approval of Praxbind now provides me and my colleagues with an important option to manage patients taking Pradaxa in situations when speed of reversal matters.” However, even though rare, there will be situations when reversal of anticoagulation is medically necessary,” said Professor Harald Darius, lead investigator for the RE-VERSE AD clinical study in Germany, and Director of the Department of Cardiology, Vascular Medicine, Nephrology and Intensive Care Medicine, Vivantes Neukoelln Medical Centre, Berlin. “Anticoagulants offer important benefits to patients at risk of thromboembolic events. Idarucizumab is the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant (NOAC) to be approved in the European union.

The European Commission has approved Boehringer Ingelheim’s Praxbind (idarucizumab), a treatment to rapidly and specifically reverse the anticoagulant effects of Pradaxa (dabigatran etexilate) in cases of emergency surgery /urgent procedures or in situations of life-threatening or uncontrolled bleeding.

Idarucizumab reversal