The Committee for Medicinal Products for Human Use of the European Medicines Agency gave thumbs up to apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (AF) and one or more risk factors for stroke.
The committee’s positive opinion will be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU). The final decision will be applicable to all 27 EU member states plus Iceland and Norway. In 2011, apixaban received regulatory approval in the 27 EU countries for the prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery.
The positive opinion was based on the ARISTOTLE and AVERROES studies, according to the drugmakers. ARISTOTLE researchers reported that apixaban was superior to warfarin in reducing stroke and systemic embolism in AF patients. A secondary analysis of the ARISTOTLE trial that investigated outcomes by type of AF found that apixaban was superior to warfarin in reducing stroke and systemic embolism, major bleeding and all-cause mortality in patients with either paroxysmal or persistent/permanent AF.
EVERROES researchers reported that apixaban reduced the risk of stroke or systemic embolism by more than 50 percent in AF patients who were deemed unsuitable to receive vitamin K antagonists without increasing the risk of major bleeding or intracranial hemorrhage.
Apixaban, a direct factor Xa inhibitor, has yet to be approved for any indication in the U.S.