RIDGEFIELD, Conn., Nov. 15, 2016 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced updated results from data for 494 patients participating in the ongoing phase III RE-VERSE AD™ study, which showed that administration of 5g of idarucizumab immediately reversed the anticoagulant effect of dabigatran, the active ingredient in Pradaxa® (dabigatran etexilate mesylate). Idarucizumab, marketed in the U.S. as Praxbind®, is the first specific reversal agent for a novel oral anticoagulant (NOAC) approved by the U.S. Food and Drug Administration (FDA), and RE-VERSE AD is the largest patient study investigating a reversal agent for a NOAC. The updated results from this expanded interim analysis were presented today at the American Heart Association (AHA) Scientific Sessions 2016 in New Orleans, Louisiana. RE-VERSE AD includes the types of patients healthcare professionals may treat in real world emergency settings. The study enrolled patients treated with dabigatran who had uncontrolled or life-threatening bleeding (Group A, n=298, 60%) or required emergency surgery or an invasive procedure (Group B, n=196, 40%). This includes severely ill or injured patients (e.g., patients in an automobile accident with multiple injuries, patients with aortic aneurysm, patients receiving an organ transplant) who as such require urgent reversal of dabigatran. The primary endpoint of reversal of the anticoagulant effect of dabigatran within four hours was 100 percent, as measured by diluted thrombin time (dTT) and ecarin clotting time (ECT) (95% CI, 100-100). Of note, reversal was evident immediately after administration of idarucizumab. For Group A patients with extracranial bleeding, median time to confirmation of hemostasis was 3.5 to 4.5 hours, depending on anatomical location. The source of bleeding was similar to the previous interim analysis (45% GI, 33% ICH). In Group B, 93 percent of patients experienced normal hemostasis during surgery, and the median time to the operating room was 1.6 hours after administration of idarucizumab.