Boehringer Ingelheim launches RE-VECTO Global Program to capture data on Praxbind usage in clinical practice
RE-VECTO will provide insights into the diverse types of situations in which reversal of an anticoagulant is performed in clinical practice.
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. 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 50 states," said Sabine Luik, 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.
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