EU approves Praxbind (idarucizumab) as antidote to Pradaxa in uncontrolled bleeding- Boehringer Ingelheim
The European Commission has licensed Praxbind (idarucizumab), from Boehringer Ingelheim, 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.
The licence 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 at least 12 hours in almost all patients. In the data submitted for authorisation, including 123 patients from RE-VERSE AD and more than 200 volunteers previously given idarucizumab no safety concerns or prothrombotic signals were observed.
Comment: The licensing 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 already licensed by the FDA in October 2015.
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