FDA Committee Unanimously Supports Boehringer Ingelheim’s Stroke-Prevention Drug in Atrial Fibrillation

The FDA Cardiovascular and Renal Drugs Advisory Committee voted 9 to 0 in favor of approving Boehringer Ingelheim’s dabigatran etexilate for stroke prevention in patients with atrial fibrillation (AFib). Dabigatran etexilate is an oral direct thrombin inhibitor being studied in the prevention and treatment of acute and chronic thromboembolic diseases.

For 50 years, warfarin has been the only oral anticoagulant available in the U.S. for stroke prevention in patients with AFib, Boehringer Ingelheim points out. Current guidelines for patients with nonvalvular AFib treated with warfarin recommend maintaining an INR control range of 2.0–3.0 through regular blood monitoring and dose adjustments.

The Phase III RE-LY study, upon which the panel’s recommendation was based, established the safety and efficacy profile of dabigatran without INR monitoring, dose adjustments, or food restrictions, the company notes. Bleeding and gastrointestinal events were the most commonly reported adverse events in this trial.

RE-LY was a global randomized trial of 18,113 patients enrolled in 951 centers in 44 countries. It was investigating whether two blinded doses of dabigatran etexilate were as effective as well-controlled warfarin for stroke prevention. Patients with nonvalvular AFib and at least one other risk factor for stroke were enrolled in the study for two years with a minimum follow-up period of one year. Other risk factors included previous ischemic stroke, transient ischemic attack, systemic embolism, left ventricular dysfunction, age greater than or equal to 75 years, and age greater than or equal to 65 years with either diabetes mellitus, history of coronary artery disease, or hypertension.