Final Phase III study results reinforce safety and efficacy of Praxbind

Final results from the RE-VERSE AD study show that idarucizumab, marketed in the USA as Praxbind, was able to immediately reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate) in patients in emergency situations, says Germany’s Boehringer Ingelheim, the maker of both drugs.

The effects were consistent both in patients requiring an urgent surgery or intervention, and in patients presenting with uncontrollable or life-threatening bleeding. The reversal of the anticoagulant effect of Pradaxa allowed physicians to quickly initiate necessary emergency interventions. The findings were presented at the International Society on Thrombosis and Hemostasis (ISTH) 26th Biennial Congress in Berlin, Germany, and simultaneously published in the New England Journal of Medicine.

The primary endpoint of RE-VERSE AD was reversal of the anticoagulant effect of Pradaxa within four hours as measured by diluted thrombin time (dTT) and ecarin clotting time (ECT), and was observed in 100% of patients (95% CI, 100-100). Reversal became evident immediately after administration of idarucizumab and was maintained for 24 hours in most patients. Reversal was independent of age, sex, kidney function or dabigatran concentration at baseline. A single 5g dose of idarucizumab was sufficient in 98% of patients.