Boehringer Ingelheim has announced its global RE-VECTO program for Praxbind® (idarucizumab), the specific reversal agent for Pradaxa® (dabigatran etexilate mesylate). PRAXBIND is indicated for patients treated with PRADAXA, when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. This indication is approved under accelerated approval based on a reduction in unbound dabigatran and normalization of coagulation parameters in healthy volunteers. Continued approval for this indication may be contingent upon the results of an ongoing cohort case series study. The emergency situations in which PRAXBIND may be used can vary greatly, such as a car accident requiring emergency surgery or a severe bleeding event. Data captured in RE-VECTO will help to better understand the actual usage of PRAXBIND in the clinical practice setting.
"PRAXBIND was made available immediately following FDA approval in October 2015, and is now stocked in more than 2,760 hospital pharmacies in all fifty states," said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "By their nature, every emergency situation is unique. We believe that RE-VECTO will provide important additional insights into the different situations PRAXBIND is used in. This may ultimately help improve care for PRADAXA patients in the rare event that reversal is needed."
Data for RE-VECTO will be captured through hospital pharmacies where PRAXBIND is dispensed and will include information about the types of patients and situations in which PRAXBIND was utilized. 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. Accelerated approval for PRAXBIND was granted based on results from Phase I data in healthy volunteers and the efficacy and safety of PRAXBIND continues to be evaluated in RE-VERSE AD™ - a phase III global clinical trial. Results from an interim analysis of RE-VERSE AD show that PRAXBIND immediately reversed the anticoagulant effect of dabigatran, the active ingredient in PRADAXA, in critically ill and high-risk patients in emergency situations.
About RE-VECTO
The global, multi-centre RE-VECTO Surveillance Program will collect data on PRAXBIND usage patterns in a clinical practice setting. The program will enroll at least 300 patients, and all hospital pharmacies where PRAXBIND is used are eligible to participate. Collected data will include information such as:
- The hospital pharmacy dispensing PRAXBIND
- Patient characteristics
- Why PRAXBIND was used – which hospital department administered it, under what circumstances, total dose administered, timings of administration, and if any adverse events occurred.
Study completion is expected by the end of 2018.