The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has unanimously recommended the approval of dabigatran etexilate for stroke prevention in patients with atrial fibrillation, with all nine members voting in favour of the drug.
For 50 years, the only oral anticoagulant available for stroke prevention in patients with atrial fibrillation was warfarin, which required patients to maintain an INR control range of two to three through regular blood monitoring and food adjustments.
However, a randomised Phase III trial proved the safety and efficacy profile of dabigatran etexilate without the need for INR monitoring, dose adjustments or food restrictions.
The global study enrolled 18,113 patients across 951 centres in 44 countries, and evaluated whether the drug was as effective at preventing stroke in patients with atrial fibrillation as warfarin.
Atrial fibrillation is a common heart rhythm disorder, which is associated with up to 15% of all strokes in the US.