Bristol-Myers Squibb and Pfizer have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of apixaban (Eliquis) for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation 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 positive opinion was based on the pivotal ARISTOTLE and AVERROES studies. These clinical studies evaluated apixaban in approximately 24,000 patients with non-valvular atrial fibrillation in the largest clinical trial programme conducted to date in this patient population.
The landmark ARISTOTLE trial compared apixaban to warfarin, the standard of care, in more than 18,000 non-valvular atrial fibrillation patients, while AVERROES compared apixaban to aspirin in 5,598 non-valvular atrial fibrillation patients who were unsuitable for vitamin K antagonist (VKA) therapy.
Apixaban is not approved for the prevention of stroke or systemic embolism in patients with atrial fibrillation in any country. In May 2011, Bristol-Myers Squibb and Pfizer announced the first regulatory approval for apixaban in the 27 countries of the European Union plus Iceland and Norway for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.
Apixaban is also being investigated in phase 3 trials for the treatment of VTE.