Boehringer Ingelheim's Praxbind Approved in Europe for Reversal of Pradaxa

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. 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.

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 was approved by the US Food and Drug Administration in October 2015.

According 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. 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. In the data submitted for approval, including 123 patients from REVERSE-AD and more than 200 volunteers previously given idarucizumab, no safety concerns or prothrombotic signals were observed.

The company advised that it is committed to making idarucizumab available as widely as possible and will launch idarucizumab in the European Union countries as soon as national requirements allow.

In the company’s press release, Prof. Harald Darius, MD, commented, “Anticoagulants offer important benefits to patients at risk of thromboembolic events. However, though rare, there will be situations when reversal of anticoagulation is medically necessary. 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.” Prof. Darius is Lead Investigator for the RE-VERSE AD clinical study in Germany. He is the Director of the Department of Cardiology, Vascular Medicine, Nephrology, and Intensive Care Medicine at Vivantes Neukoelln Medical Centre in Berlin, Germany.