The FDA Cardiovascular and Renal Drugs Advisory
Committee has 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.(2) The RE-LY study established
the safety and efficacy profile of dabigatran(3) without INR monitoring,
dose adjustments or food restrictions.(3)
“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.”
