Boehringer Ingelheim presented results from an interim analysis of its Phase 3 RE-VERSE AD study, which demonstrates that 5g of idarucizumab (humanized antibody fragment) enabled emergency surgery to be initiated rapidly in urgent situations involving patients treated with Pradaxa (dabigatran etexilate mesylate). The results were presented at the European Society of Cardiology Congress 2015.
RE-VERSE AD, a Phase 3 global study, includes Pradaxa-treated patients who have uncontrolled or life-threatening bleeding or require emergency procedures. Patients were categorized into two groups – (A) patients with uncontrolled or life-threatening bleeding complications, e.g. intracranial hemorrhage or severe trauma after a car accident or (B) patients requiring emergency surgery or an invasive procedure, e.g. surgery for an open fracture after a fall. The primary endpoint of the study is the degree of reversal of the anticoagulant effect of dabigatran achieved by 5g of idarucizumab within four hours measured by diluted thrombin time (dTT) and ecarin clotting time (ECT).
The interim analysis from RE-VERSE AD included data from patients requiring emergency surgery or an invasive procedure (e.g., surgery for an aortic aneurysm or an open fracture after a fall), which could not be delayed for more than eight hours. The specific and immediate reversal of the anticoagulant effect of dabigatran enabled patients to be urgently brought to necessary procedures, with a median time of 1.7 hours between administration of idarucizumab and start of procedure. Normal blood clotting during surgery was reported in 92% of patients and no post-surgical bleeding complications were reported in the 24 hours post-surgery.
The Food and Drug Administration (FDA) granted Priority Review to the Biologics License Application (BLA) for idarucizumab in April 2015.
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