Boehringer Ingelheim has announced the launch of its global RE-VECTO programme for idarucizumab (Praxbind), the specific reversal agent for dabigatran etexilate (Pradaxa).
Idarucizumab is approved to reverse the anticoagulant effects of dabigatran in rare critical care situations such as prior to emergency surgery or an urgent intervention, or in cases of life-threatening or uncontrolled bleeding. The emergency situations in which idarucizumab 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.
“Praxbind received its first approval in the US nearly a year ago and is now widely available in the USA, the EU and several other countries worldwide,” says 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 programme 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 idarucizumab is dispensed. The data collected will include anonymous information about the types of patients and situations in which idarucizumab was utilised. The data gathered from RE-VECTO will help shape future information and education on idarucizumab to healthcare providers and patients.
Idarucizumab 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 dabigatran is required. The efficacy and safety of idarucizumab continues to be evaluated in RE-VERSE AD ‒ a phase III global clinical trial. It is designed to evaluate the types of patients and real-world situations healthcare professionals may see in emergency settings. The broad inclusion criteria ensure that even the most severely ill or injured patients (eg. patients with sepsis or a severe intracranial haemorrhage), who require urgent reversal of dabigatran, may be enrolled in the study. 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.
Study completion is expected by the end of 2018.