Bristol-Myers Squibb and Pfizer to Present New Data on Eliquis (apixaban) at the ESC Congress 2015
OREANDA-NEWS. Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) announced today that 22 abstracts (late-breaking, rapid-fire, oral and poster presentations) will be presented at the ESC Congress 2015, to be held August 29 to September 2 in London, United Kingdom. The new data reinforce the Alliance’s commitment to the ongoing evaluation of Eliquis in both the nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE) patient populations. In addition, data from the AEGEAN (Assessment of an Educational and Guidance Programme for Eliquis Adherence in Nonvalvular Atrial Fibrillation) study evaluating adherence among NVAF patients further extends the Alliance’s commitment to patient care.
“The Bristol-Myers Squibb and Pfizer Alliance is pleased to share 22 abstracts, which include important Eliquis data from both clinical trials and real-world analyses, at one of the world’s largest and most influential cardiovascular meetings,” said Douglas Manion, M.D., head of specialty development, Bristol-Myers Squibb.
“Clinical trial data are important in evaluating a medication’s efficacy and safety under well-controlled circumstances, and their findings can be supplemented by real-world data on the use of a product for approved indications in routine clinical practice,” said Rory O’Connor, M.D., senior vice president and head of Global Medical Affairs, Global Innovative Pharmaceuticals Business, Pfizer Inc.
Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood-clotting protein, Eliquis decreases thrombin generation and blood clot formation. Eliquis is approved for multiple indications in the U.S. based on efficacy and safety data, including results from seven Phase 3 clinical trials. Eliquis is a prescription medicine indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery; for the treatment of DVT and PE; and to reduce the risk of recurrent DVT and PE following initial therapy.
About ARISTOTLE and APPRAISE-2
ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) was designed to evaluate the efficacy and safety of Eliquis versus warfarin for the prevention of stroke or systemic embolism. In ARISTOTLE, 18,201 patients were randomized (9,120 patients to Eliquis and 9,081 to warfarin). ARISTOTLE was an active-controlled, randomized, double-blind, multi-national trial in patients with nonvalvular atrial fibrillation or atrial flutter, and at least one additional risk factor for stroke. Patients were randomized to treatment with Eliquis 5 mg orally twice daily (or 2.5 mg twice daily in selected patients, representing 4.7 percent of all patients) or warfarin (target INR range 2.0-3.0), and followed for a median of 1.8 years.
APPRAISE-2 (Apixaban for Prevention of Acute Ischemic Events – 2) evaluated Eliquis in patients at risk of ischemic events. It was designed to randomize approximately 10,800 patients with a recent acute coronary syndrome (ACS) to Eliquis 5 mg twice daily or placebo, in addition to mono or dual antiplatelet therapy. The study was stopped early based on the recommendation of an independent Data Monitoring Committee (DMC). There was clear evidence of a clinically important increase in bleeding among patients randomized to Eliquis. This increase in bleeding was not offset by clinically meaningful reductions in ischemic events.
About the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, an 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.
About Pfizer Inc.: Working together for a healthier world™
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us.