FDA Advisory Committee recommends approval of dabigatran etexilate for stroke prevention in AFib patients

The U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee today 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 the prevalence is expected to increase 2.5 fold to 5.6 million by 2050, reflecting the growing population of elderly individuals.

For 50 years, warfarin has been the only oral anticoagulant available in the U.S. 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. The RE-LY study established the safety and efficacy profile of dabigatran without INR monitoring, dose adjustments or food restrictions.

"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., M.P.H., U.S. medical director, Boehringer Ingelheim Pharmaceuticals, Inc. "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."