"With this approval, Boehringer Ingelheim is again leading the evolution of anticoagulation care, as we did with the introduction of Pradaxa®. "I am delighted that we are now able to offer Praxbind®, the only specific reversal agent for a NOAC, to patients and physicians in Europe," commented Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. "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. (1) Idarucizumab is the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant (NOAC) to be approved in the European union.(1) The European Commission has approved 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.
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