Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) announced today that 17 abstracts will be presented at the American College of Cardiology's 65th Annual Scientific Session (ACC.16), to be held April 2-4 in Chicago, IL. The new analyses contribute to the Bristol-Myers Squibb and Pfizer Alliance's body of evidence on the use of Eliquis to reduce the risk of stroke in patients with nonvalvular atrial fibrillation (NVAF) and for the treatment of patients with venous thromboembolism (VTE). Abstracts include new analyses from Phase 3 ARISTOTLE and AMPLIFY clinical studies, as well as a number of retrospective analyses of real-world data. "The Alliance is pleased to present new analyses from both Phase 3 clinical trials and real-world databases at this important cardiology conference," said Douglas Manion, M.D., head of specialty development, Bristol-Myers Squibb. "Clinical trial data help to evaluate the safety and efficacy of Eliquis under well-controlled circumstances, while real-world data can offer additional insight into the use of Eliquis for its approved indications in routine clinical practice."
The real-world data to be presented at ACC.16 are part of ACROPOLIS™ (Apixaban ExperienCe Through Real-WOrldPOpuLatIon Studies), a global real-world data research program designed to further evaluate the effectiveness and safety of Eliquisin routine clinical practice. "Retrospective analyses of real-world data add an important component to our knowledge of Eliquis and may help to inform healthcare practitioners in their treatment decisions," said Rory O’Connor, M.D., senior vice president and head of Global Medical Affairs, Global Innovative Pharmaceuticals Business, Pfizer Inc.
About Eliquis
Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquisdecreases thrombin generation and blood clot formation. Eliquis is approved for multiple indications in the U.S. based on efficacy and safety data 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 (NVAF); 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 ACROPOLIS™
ACROPOLIS™ (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies) is the Eliquis (apixaban) global real-world data program designed to generate additional evidence from routine clinical practice settings to further inform healthcare decision makers, including healthcare providers and payers. The ACROPOLIS program will include retrospective, outcomes-based analyses from over 10 databases around the world, including medical records, medical and pharmacy health insurance claims data, and national health data systems.
Analyses of real-world data allow for a broader understanding of patient outcomes associated with Eliquis outside of the clinical trial setting, as well as insight into other measures of healthcare delivery, such as hospitalization and costs.
About AMPLIFY
The AMPLIFY (Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY) trial was a double-blind, randomized, multicenter study that compared the efficacy and safety of Eliquis (at a dose of 10 mg orally twice daily for seven days, followed by 5 mg orally twice daily for six months) with those of conventional therapy in 5,395 patients with symptomatic proximal DVT or symptomatic PE with or without DVT. The primary efficacy outcome was the incidence of the adjudicated composite of recurrent symptomatic VTE or death related to VTE that occurred by the end of the treatment period. The primary safety outcome was adjudicated major bleeding that occurred by the end of the treatment period.
About ARISTOTLE
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.
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 Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
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.