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


The US FDA cardiovascular and renal drugs advisory committee today voted 9 to 0 in favour 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 US 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. “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”.

About the RE-LY trial

RE-LY was a global, Phase III, randomised trial of 18,113 patients enrolled in 951 centres 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 were enrolled in the study for two years with a minimum follow-up period of one year.

The RE-LY trial utilised the established PROBE (prospective, randomised, open-label, blinded endpoint evaluation) clinical trial protocol, which has been used in the majority of previous trials of anticoagulation for stroke prevention in patients with AFib. A PROBE design is more reflective of the differences in the management of warfarin and dabigatran in clinical practice.

In the RE-LY trial, all clinical outcomes were adjudicated in a blinded manner to minimise bias in assessment of outcomes for each treatment.

Bleeding and gastrointestinal events were the most commonly reported adverse events in this trial.