The results from an interim analysis of the phase III RE-VERSE AD patient study presented by lead investigator Charles Pollack, professor of emergency medicine at the Perelman School of Medicine of the University of Pennsylvania School of Medicine, Philadelphia, demonstrated that 5 grams of idarucizumab* immediately reversed the anticoagulant effect of dabigatran etexilate in patients requiring urgent anticoagulant reversal. This interim analysis included 90 dabigatran-treated patients and provides the first insights on the effect of a specific reversal agent to a non-vitamin K antagonist oral anticoagulant during real-world emergency situations. The results were presented on Monday 22 June in the Late Breaking Clinical Trial Abstract session – Thrombosis and Anticoagulation at the ISTH Congress and have been simultaneously published in the New England Journal of Medicine (NEJM).

In the interim analysis, reversal was evident immediately after administration of idarucizumab and was complete in all but 1 patient. After 4 and 12 hours, laboratory tests showed normal coagulation levels in almost 90 percent of patients. Normal hemostasis during surgery was reported in 92 percent of the patients who required urgent surgery or invasive procedures. No safety concerns or signal of a pro-coagulant effect following administration of idarucizumab were identified in the analysis.

RE-VERSE AD has been designed to evaluate the types of dabigatran-treated patients and real-world situations that might be seen by physicians in emergency settings. The study enrolls patients treated with dabigatran who require emergency surgery or an invasive procedure or who present with uncontrolled or life-threatening bleeding complications.

Idarucizumab is currently under accelerated review with regulatory authorities in the United States, Canada and Europe with further regulatory submissions ongoing.

* Idarucizumab is the recommended International Nonproprietary Name (INN). Idarucizumab is an investigational drug, which has not been approved for clinical use, and further safety and efficacy testing will be required.

By |June 22, 2015