FDA Approves Apixaban to Prevent Stroke in Nonvalvular AF

December 28, 2012

Rockville, MD — The US Food and Drug Administration (FDA) has approved apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF).

Apixaban is the third anticoagulant to be approved in the US for this indication, following the direct thrombin inhibitor dabigatran (Pradaxa, Boehringer Ingelheim) and the factor Xa inhibitor rivaroxaban (Xarelto, Bayer/Johnson & Johnson). Like rivaroxaban, apixaban is a factor Xa inhibitor.

The US approval is based on the positive results from the ARISTOTLE trial — first reported at the European Society of Cardiology meeting in 2011 and published simultaneously in the New England Journal of Medicine — and the AVERROES trial. In a press release accompanying the US approval, the FDA states that patients taking apixaban had significant fewer strokes than patients who took warfarin.

Apixaban was approved in Europe for the prevention of stroke and systemic embolism in nonvalvular AF in late November and was approved by Health Canada just a few weeks ago. The US delay occurred as the FDA requested more information from Bristol-Myers Squibb and Pfizer this past June. No new studies were required, but additional information on data management and verification was requested from the ARISTOTLE trial.

The agency warned today that patients with a prosthetic heart valve or AF caused by a heart valve problem should not take apixaban. The FDA and European Medicines Agency (EMA) recently warned that dabigatran should not be used in patients with mechanical prosthetic heart valves.