FDA committee recommends approval of dabigatran for stroke prevention in atrial fibrillation

October 19, 2010

FDA's Cardiovascular and Renal Drugs Advisory Committee voted 9 to 0 on Sept. 20 in favor of approving dabigatran etexilate (Pradaxa) for stroke prevention in patients with atrial fibrillation.

FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9 to 0 on Sept. 20 in favor of approving dabigatran etexilate (Pradaxa) for stroke prevention in patients with atrial fibrillation (AFib).

For 50 years, warfarin (Coumadin, Bristol-Myers Squibb) 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.

Researchers established the safety and efficacy profile of dabigatran without INR monitoring, dose adjustments, or food restrictions through the RE-LY study. RE-LY was a global, phase 3, randomized trial of 18,113 patients enrolled in 951 centers in 44 countries, investigating whether dabigatran etexilate (two blinded doses) was as effective as well-controlled warfarin - INR 2.0 – 3.0 - (open label) for stroke prevention. Patients with non-valvular AFib and at least one other risk factor for stroke (i.e., previous ischemic stroke, transient ischemic attack, or systemic embolism, left ventricular dysfunction, ≥75 years, ≥65 with either diabetes mellitus, history of coronary artery disease, or hypertension) were enrolled in the study for 2 years with a minimum follow-up period of 1 year.

“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, MD, MPH, U.S. medical director for Ridgefield, Conn.-based 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.”

An estimated 2.3 million Americans have AFib, and the prevalence is expected to increase to 5.6 million by 2050, reflecting the growing elderly population.