Phase 3 ARISTOTLE Study of Apixaban Meets Primary Endpoints

June 22, 2011—Bristol-Myers Squibb Company (Plainsboro, NJ) and Pfizer Inc. (New York, NY) announced results of the ARISTOTLE trial of Eliquis, a new oral direct Factor Xa inhibitor that is being developed by an alliance of the two companies. Eliquis is the approved trade name for apixaban in Europe and the proposed trade name in the United States and other countries.

According to the companies, ARISTOTLE is a double-blind, multicenter, head-to-head phase 3 trial that randomized 18,201 patients with atrial fibrillation from more than 1,000 centers in approximately 40 countries. Patients were randomized to receive either Eliquis 5 mg twice daily (2.5 mg twice daily in selected patients) or dose-adjusted warfarin (titrated to a target international normalized ratio range of 2 to 3). The detailed results of the ARISTOTLE study will be presented on August 28 at the European Society of Cardiology Congress 2011 in Paris.

In this study of patients with atrial fibrillation and at least one additional risk factor for stroke, Eliquis met the primary efficacy objective of noninferiority to warfarin on the combined outcome of stroke (ischemic, hemorrhagic, or unspecified type) and systemic embolism. In addition, Eliquis met the key secondary endpoints of superiority on efficacy and on ISTH (International Society on Thrombosis and Hemostasis) major bleeding compared to warfarin.

Bristol-Myers Squibb and Pfizer advised that Eliquis is not approved for the prevention of stroke in patients with atrial fibrillation, but that the companies expect to submit regulatory filings in the United States and Europe in the third or fourth quarter of 2011.

The companies noted that Eliquis is being investigated within the EXPANSE clinical trials program, which is projected to include nearly 60,000 patients worldwide across multiple indications and patient populations and is composed of nine completed or ongoing, randomized, double-blind phase 3 trials, including ARISTOTLE.

Bristol-Myers Squibb and Pfizer recently announced the European regulatory approval of Eliquis for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.

In addition to stroke prevention in patients with atrial fibrillation and the prevention of VTE in patients who have undergone total hip or total knee replacement surgery, Eliquis is being investigated in phase 3 trials for the treatment of VTE and the prevention of VTE in hospitalized, acutely ill medical patients.