25 September 2015 - Today, the Committee for Medicinal Products for Human use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending European approval of idarucizumab (to be marketed as Praxbind).1 Idarucizumab is intended for use in adult patients treated with Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required for emergency surgery / urgent procedures or in life-threatening or uncontrolled bleeding.

“The CHMP positive opinion in favour of idarucizumab approval is an important recommendation in the field of anticoagulation care,” said Professor Fausto J. Pinto, University of Lisbon, Portugal, and President of the European Society of Cardiology. “The introduction of non-vitamin K antagonist oral anticoagulants, or NOACs, already marked a significant advancement in anticoagulation care. The approval of specific reversal agents to stop their anticoagulant effect immediately when needed will be the next advancement.”

“This will be the icing on the cake for treating our stroke patients with anticoagulants like dabigatran: in an emergency we will be able to switch off their treatment almost instantly, and safely. This will make treatment choices much easier for both doctor and patient,” stated Professor Kennedy R. Lees, University of Glasgow, UK, and President of the European Stroke Organisation.

For more details, go to: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/25_september_2015_pradaxa.html