Praxbind® (idarucizumab) approved in European Union for the specific reversal of Pradaxa® (dabigatran etexilate)

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.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

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“Anticoagulants offer important benefits to patients at risk of thromboembolic events. 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. “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.”

“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. “With this approval, Boehringer Ingelheim is again leading the evolution of anticoagulation care, as we did with the introduction of Pradaxa^®. And while we anticipate that Praxbind^® will be rarely used in clinical practice, the availability of this specific reversal agent can now give physicians and patients added confidence in choosing Pradaxa^®.”

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 2015.⁵ Idarucizumab was already approved by the U.S. Food and Drug Administration in October 2015.⁶

The approval is based on data from healthy volunteers, as well as results from an interim analysis of the RE-VERSE AD™ clinical study.^2-4,7 In the studies, the reversal effects of idarucizumab were evident immediately, within minutes after administration of 5 grams of idarucizumab.^2-4 Reversal was complete and sustained for a minimum of 12 hours in almost all patients.^2-4 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.^2-4,7,8

Boehringer Ingelheim 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.¹

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’: https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/26_november_2015_pradaxa.html

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