October 4, 2010 – The U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee voted 9 to 0 in favor of approving dabigatran etexilate for stroke prevention in patients with atrial fibrillation (AFib). An estimated 2.3 million Americans have AFib, and that number is expected to more than double by 2050.
The RE-LY study established the safety and efficacy profile of dabigatran, an oral direct thrombin inhibitor, without INR monitoring, dose adjustments or food restrictions.
For 50 years, warfarin has been the only oral anticoagulant available in the United States for stroke prevention in patients with AFib. Current guidelines for patients with non-valvular AFib treated with warfarin recommend maintaining an INR control range of 2.0-3.0 through regular blood monitoring and dose adjustments.
"We are pleased with the committee's unanimous recommendation, which marks an important step in advancing care for patients with atrial fibrillation," said Christopher Corsico, M.D., MPH, U.S. medical director, Boehringer Ingelheim Pharmaceuticals. "We believe dabigatran etexilate will offer patients and doctors the first new treatment option for stroke prevention in atrial fibrillation in more than 50 years. We look forward to working with the FDA as it finalizes its review of dabigatran."
RE-LY was a global Phase III trial investigating whether dabigatran etexilate was as effective as well-controlled warfarin for stroke prevention. Patients with non-valvular 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.
The trial utilized the established PROBE (prospective, randomized, open-label, blinded endpoint evaluation) protocol, which is more reflective of the differences in the management of warfarin and dabigatran in clinical practice.
Atrial fibrillation is the most common significant heart rhythm disorder and is associated with a nearly five-fold increased risk of stroke.
Dabigatran etexilate has not been approved by the FDA and is currently an investigational oral direct thrombin inhibitor.
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