The European Commission cleared Boehringer Ingelheim’s oral anticoagulant Pradaxa® (dabigatran etexilate) for preventing stroke in atrial fibrillation (AF) patients at risk of stroke. Equivalent approvals have previously been granted for the drug in the U.S., Canada, Japan, Australia, and a number of other countries. BI claims the EU label extension provides patients in Europe with the first new treatment in over 50 years for the prevention of AF-related stroke. The direct thrombin inhibitor was first approved in Europe in 2008 for the primary prevention of venous thromboembolic events in adults who have undergone elective total hip or elective total knee replacement surgery, and is now approved in over 75 countries for the VTE prevention indication.
EC approval for the AF stroke indication was based on data from the open label, blinded endpoint evaluation study RE-LY®, which represented one of the largest studies ever conducted in AF patients, BI notes. The 18,000 patient trial compared one of two fixed doses of dabigatran etexilate (110 mg and 150 mg) administered twice daily, with treatment using open-label warfarin. The results showed that in comparison with warfarin therapy, Pradaxa 150 mg reduced the risk of stroke and systemic embolism in AF patient by an extra 35%, while significantly reducing the risk of life-threatening and intracranial bleeding. Benefits were observed in AF patients irrespective of age, gender, stroke risk, type of AF, prior stroke, and co-morbidities such as hypertension and diabetes, notes Stuart Connolly, director of McMaster University’s division of cardiology and co-principal investigator for the RE-LY study.
BI’s Pradaxa clinical trial program, RE-volution®, aims to evaluate the drug for a range of indications including primary VTE prevention, AF-related stroke prevention secondary VTE prevention, acute VTE treatment, and the secondary prevention of cardiac events in patients with acute coronary syndrome. The trial program is projected to include some 40,000 patients.