INGELHEIM, Germany - Monday, August 15th 2016 [ME NewsWire]
Praxbind® (idarucizumab) is the specific reversal agent for the oral anticoagulant Pradaxa® (dabigatran)1,2
Praxbind® is already available in over 5,000 hospitals worldwide and is approved in over 35 countries3
RE-VECTO will provide insights into the diverse types of situations in which reversal of an anticoagulant is performed in clinical practice
(BUSINESS WIRE)-- Boehringer Ingelheim today announces its global RE-VECTO program for Praxbind® (idarucizumab), the specific reversal agent for Pradaxa® (dabigatran etexilate).1,2 Praxbind® is approved to reverse the anticoagulant effects of Pradaxa® in rare critical care situations such as prior to emergency surgery or an urgent intervention, or in cases of life-threatening or uncontrolled bleeding.1,2 The emergency situations in which Praxbind® may be used can vary greatly, ranging from a severe car accident to a ruptured appendix. Data captured in RE-VECTO will help better understand the actual usage of the reversal agent in the clinical practice setting.4
“Praxbind® received its first approval in the US nearly a year ago and is now widely available in the US, the EU and several other countries worldwide,” said Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “By their nature, every emergency situation is unique. We have already seen this in our RE-VERSE AD™ clinical study, which could enrol all adult patients taking Pradaxa® in need of reversal, and captured a broad variety of patients and situations. RE-VECTO is an additional program designed to further our understanding of the different situations in which Praxbind® is used in clinical practice. This will ultimately help improve care for patients treated with Pradaxa® in the rare event that reversal is needed.”
The data for RE-VECTO will be captured through hospital pharmacies where Praxbind® is dispensed.5 The data collected will include anonymous information about the types of patients and situations in which Praxbind® was utilised.5 The data gathered from RE-VECTO will help shape future information and education on Praxbind® to healthcare providers and patients.
Praxbind® is the first and only specific non-vitamin K antagonist oral anticoagulant (NOAC) reversal agent approved for use in emergency situations when immediate reversal of the anticoagulant effect of Pradaxa® is required.1,2 The efficacy and safety of idarucizumab continues to be evaluated in RE-VERSE AD™ - a Phase III global clinical trial.6 It is designed to evaluate the types of patients and real-world situations healthcare professionals may see in emergency settings.7,8 The broad inclusion criteria ensure that even the most severely ill or injured patients (e.g. patients with sepsis or a severe intracranial haemorrhage), who require urgent reversal of dabigatran, may be enrolled in the study.7,8,9 Results from an interim analysis of RE-VERSE AD™ showed that idarucizumab immediately reversed the anticoagulant effect of dabigatran even in critically ill and high-risk patients in emergency situations.7
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
Phone: +49 6132 – 77 141575
Fax: +49 6132 – 77 6601