RE-VECTO Global Program Will Capture Clinical Practice Data on Boehringer Ingelheim's Praxbind

August 15, 2016—Boehringer Ingelheim Pharmaceuticals, Inc. announced the initiation of its global RE-VECTO program, which will capture data on Praxbind (idarucizumab) to provide insights into the diverse types of situations in which reversal of an anticoagulant is performed in clinical practice. Praxbind is the specific reversal agent for the company’s oral anticoagulant 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, advised the company.

According to Boehringer Ingelheim, data captured in RE-VECTO will help to better understand the actual usage of Praxbind in the clinical practice setting. The data 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 will help shape future information and education on Praxbind to health care providers and patients.

Praxbind is a specific nonvitamin K antagonist oral anticoagulant reversal agent approved for use in emergency situations when immediate reversal of the anticoagulant effect of Pradaxa is required. 

In October 2015, the company announced the US Food and Drug Administration accelerated approval for Praxbind based on results from phase 1 data in healthy volunteers. European approval was announced in November 2015. 

The efficacy and safety of Praxbind continues to be evaluated in RE-VERSE AD, a phase 3 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, stated Boehringer Ingelheim.