Bristol-Myers Squibb (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that ELIQUIS
(apixaban) be granted approval for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) and one or more risk factors for stroke. The CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. The final decision will be applicable to all 27 European Union member states plus Iceland and Norway.
The positive opinion was based on the pivotal ARISTOTLE and AVERROES studies. These clinical studies evaluated apixaban in approximately 24,000 patients with NVAF in the largest clinical trial program conducted to date in this patient population. The landmark ARISTOTLE trial compared apixaban to warfarin, the standard of care, 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 (VKA) therapy.
About Atrial Fibrillation
Atrial fibrillation is the most common cardiac arrhythmia (irregular heart beat). It is estimated that approximately 6 million individuals in Europe have atrial fibrillation. The lifetime risk of developing atrial fibrillation is estimated to be approximately 25 percent for individuals 40 years of age or older. One of the most serious medical concerns for individuals with atrial fibrillation is the increased risk of stroke, which is five times higher in people with atrial fibrillation than those without atrial fibrillation. In fact, atrial fibrillation is responsible for 15-20 percent of all ischaemic strokes and 45 percent of all embolic strokes in Europe. Atrial fibrillation-related strokes are more severe than other strokes, with an associated 30-day mortality of 24 percent and a 50 percent likelihood of death within one year in patients who are not treated with an antithrombotic.