EMA CHMP adopts positive opinion for ELIQUIS to prevent stroke, systemic embolism in NVAF patients
Published on September 21, 2012 at 11:20 AM
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.
Bristol-Myers Squibb and Pfizer Inc.