Bristol-Myers Squibb And Pfizer Announce Data Presentations For Apixaban At European Society of Cardiology Congress 2011
New Data Presentations from Largest Phase 3 Clinical Trial Program for Stroke Prevention in Atrial Fibrillation
Multiple data presentations for ELIQUIS® (apixaban), an oral direct Factor Xa inhibitor being developed by Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE), will be given at the European Society of Cardiology Congress, August 27-31, 2011, in Paris, France.
Globally-conducted registrational studies evaluating ELIQUIS for the prevention of stroke in patients with atrial fibrillation will be presented during the congress. Of note is the first presentation of the comprehensive analysis of ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) during the Hot Line session on Sunday, August 28th.
Presentations on ELIQUIS at the Congress include:
About Atrial Fibrillation
Atrial fibrillation is the most common sustained cardiac arrhythmia. It is estimated that more than 5 million Americans and 6 million individuals in the European Union have AF. The lifetime risk of atrial fibrillation is estimated to be approximately one in four for individuals 40 years of age or older. The underlying threat of atrial fibrillation is the increased risk of stroke, which is five times higher in people with atrial fibrillation than those without atrial fibrillation. In fact, 15 percent of all strokes in the U.S. are attributable to atrial fibrillation.
About ARISTOTLE and AVERROES
The ELIQUIS stroke prevention in atrial fibrillation clinical trial program was designed to comprehensively evaluate ELIQUIS in approximately 24,000 patients with atrial fibrillation requiring stroke prevention, including patients who are expected or demonstrated to be unsuitable for vitamin K antagonist therapy.
ARISTOTLE, a double-blind, multicenter, head-to-head Phase 3 trial, randomized more than 18,000 patients with atrial fibrillation from over 1,000 centers in about 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 INR range of 2.0 to 3.0). The key study outcomes were prespecified in a hierarchical manner that sequentially tested ELIQUIS versus warfarin for noninferiority on the composite endpoint of stroke or systemic embolism; superiority on the composite endpoint of stroke or systemic embolism; superiority on major bleeding; and superiority on all-cause death.
The AVERROES study evaluated ELIQUIS compared to aspirin in 5,599 patients with atrial fibrillation at risk for stroke who were demonstrated or expected to be unsuitable for vitamin K antagonist therapy.
ELIQUIS is the approved trade name for apixaban in Europe and the proposed trade name in the United States. ELIQUIS is not approved in any country for the prevention of stroke in patients with atrial fibrillation. Bristol-Myers Squibb and Pfizer recently announced the first regulatory approval for ELIQUIS in the 27 countries of the European Union (EU) for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Apixaban is not currently approved in the United States.
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 includes a total of nine completed or ongoing, randomized, double-blind Phase 3 trials, including ARISTOTLE and AVERROES.
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.
About the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize ELIQUIS, an investigational oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb’s long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field.