12:09 uur 04-04-2016

Interim Phase III Data Show Praxbind® (idarucizumab) Reverses Dabigatran (Pradaxa®) in Emergency Situations

INGELHEIM, Germany–(BUSINESS WIRE)– Boehringer Ingelheim has announced the results of a new interim analysis of data from the ongoing phase III RE-VERSE AD™ patient study that showed a single 5g dose of idarucizumab immediately reversed the anticoagulant effect of dabigatran, the active ingredient in Pradaxa ® (dabigatran etexilate), in all patients evaluated. 1 Idarucizumab was the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant approved by Regulatory Authorities including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in 2015, and is marketed as Praxbind ®. 2,3 The results from this study were presented at the American College of Cardiology 65 th Annual Scientific Session (ACC.16) and Expo in Chicago. 1

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“The data from this new RE-VERSE AD™ interim analysis of the first 123 patients support earlier findings that show idarucizumab reverses the anticoagulant effect of dabigatran, including reversal in critically ill, high-risk patients in emergency care,” said Dr. Charles Pollack, lead investigator of RE-VERSE AD™, Professor of Emergency Medicine, Sidney Kimmel Medical College, Thomas Jefferson University in Philadelphia, USA. “We have enrolled patients in more than 35 countries and we look forward to the additional analyses and final results to further support the safety, effectiveness and impact of idarucizumab.”

RE-VERSE AD™ was designed to allow for the types of patients healthcare professionals may treat in real-world emergency settings. 4 Patients were categorised into two groups – (A) patients with uncontrolled or life-threatening bleeding complications (Group A, n=66), or (B) patients requiring emergency surgery or an invasive procedure (Group B, n=57). 1,4 All patients received 5g of idarucizumab, and reversal was evident in all assessable patients (n=100). 1

Among assessed patients in Group A (n=48), the median subjective investigator-reported time to cessation of bleeding was 9.8 hours. In Group B (n=52), the mean time to surgery was 1.7 hours following administration of idarucizumab. Normal blood clotting (haemostasis) during surgery was reported in 92 per cent of patients (48/52). Thrombotic events occurred in five patients between two to 24 days after idarucizumab administration. None of these patients were receiving antithrombotic therapy at the time of their event. There were 26 total deaths, which appeared to be related to the original reason for emergency admission to the hospital and/or to co-morbidities. 1

“These new data add to the body of evidence for idarucizumab and the important role it will play for patients. While emergency situations in which idarucizumab may be used are rare, we are convinced that offering a broadly available specific reversal agent will set a new level of care for patients, caregivers and healthcare providers,” said Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “Boehringer Ingelheim is committed to bringing value to patients through investment in innovation. The research, development and regulatory approvals of idarucizumab, the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant, are evidence of this commitment.”

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.


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Boehringer Ingelheim GmbH
Friederike Middeke
Phone: +49 6132 – 77 141575
Fax: +49 6132 – 77 6601
E-mail: press@boehringer-ingelheim.com< br/>Twitter: http ://twitter.com/Boehringer
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www.boehr inger-ingelheim.com

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