The European Commission will review the CHMP’s positive opinion, based on the pivotal ARISTOTLE and AVERROES studies, and will make the final decision.
The ARISTOTLE trial compared apixaban to warfarin in more than 18,000 NVAF patients, while AVERROES compared apixaban to aspirin in 5,598 NVAF patients who were unsuitable for vitamin K antagonist therapy.
Atrial fibrillation is the most common cardiac arrhythmia (irregular heart beat). It is estimated that approximately 6 million individuals in Europe have atrial fibrillation.