We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Bristol Myers Squibb Co | NYSE:BMY | NYSE | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
0.18 | 0.40% | 44.88 | 45.37 | 44.34 | 44.73 | 21,281,897 | 00:58:53 |
Eliquis® (apixaban) Clinical Data Include Results from a Phase 4 Trial – EMANATE – to be Featured in Late-Breaking Science Sessions
Analyses from the ACROPOLIS™ Global Real-World Data Program Provide Insight into the Anticoagulation of a Broad Range of NVAF Patients at Risk for Stroke
Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced that 15 abstracts have been accepted for presentation at the ESC Congress 2017, organized by the European Society of Cardiology, on August 26-30 in Barcelona, Spain. Investigational data from the EMANATE [Eliquis evaluated in acute cardioversion coMpared to usuAl treatmeNts for AnTicoagulation in subjEcts with non-valvular atrial fibrillation (NVAF)] clinical trial will be presented during the Late-Breaking Science hot line session and official ESC press conference. EMANATE is a Phase 4 clinical trial exploring Eliquis® (apixaban) versus standard of care (parenteral heparin and/or oral anticoagulation with a vitamin K antagonist) in patients with NVAF expected to undergo cardioversion to re-establish a regular heart rhythm.
In addition, analyses from ACROPOLIS™ (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies) – the real-world data program which aims to contribute to the growing body of evidence related to anticoagulation – will be presented at this year’s ESC Congress. These analyses focus on the use of Eliquis in routine clinical practice, including in NVAF patient populations considered at high risk or particularly vulnerable to stroke or major bleed due to age, risk prediction scores, and other cardiovascular comorbidities.
“We are proud to share both clinical trial results and real-world data analyses that continue to support the medical community in the advancement of patient care and add to the body of evidence for Eliquis as a treatment for DVT/PE and for reducing the risk of stroke in NVAF patients,” said Christoph Koenen, M.D., MBA, VP, Development Lead, Eliquis, Bristol-Myers Squibb. “These data supplement our pivotal trial results, providing additional insight into how Eliquis performs in specific clinical settings such as cardioversion and broad patient populations representing common clinical practice settings.”
“As physicians evaluate options for reducing stroke risk in patients with non-valvular atrial fibrillation, they often face questions about the effectiveness and safety of therapies in day-to-day practice,” said Rory O’Connor, M.D., Chief Medical Officer, Pfizer Innovative Health. “Real-world data analyses, such as the results shared at this year’s ESC Congress, allow us to better understand the usage of Eliquis and other anticoagulants in a variety of settings and alongside clinical data, and have the potential to help healthcare providers make more informed decisions about their patient’s care.”
Initial findings from a Bristol-Myers Squibb (BMS)- and Pfizer- commissioned global policy research project conducted by The Economist Intelligence Unit (EIU), the research analysis division of The Economist Group, will also be presented at the ESC Congress. These findings bring attention to the global disparity of stroke risk reduction policies, and inadequate detection of risk factors for stroke – including NVAF – in clinical practice. The full report, which will be released by The EIU on September 21, is part of the BMS-Pfizer Alliance’s commitment to collaborating with patient advocacy and research organizations around the world to uncover barriers to atrial fibrillation screening and appropriate treatment to reduce the risk of stroke for patients with NVAF.
Below is a complete list of BMS and Pfizer Alliance presentations during the ESC Congress. Abstracts can be accessed through the ESC Congress 2017 Scientific Programme.
Title Presenting Author/Type Date/Time (CET) Location/Session Clinical Data INR prior to bleeding is below 3.0 most of the time in patients with atrial fibrillation using warfarin
Session: Poster Session 3 – Drug Treatment
Oliveira Guimaraes et al./ Poster Aug. 27,14:00-18:00
Poster Area Apixaban vs conventional therapy in anticoagulation-naive patients with atrial fibrillation undergoing cardioversion: The EMANATE Trial
Sessions:
Hot Line: Late-Breaking Clinical Trials 2
Meet the Trialists - EMANATE
Ezekowitz et al./Hot Line
Meet the Trialists
Aug. 28,Hot Line: 11:18-11:28Meet the Trialists: 15:40 – 16:00 Hot Line:Main Auditorium
Meet the Trialists:
Dali – The Hub
Serial IL-6 levels and risk of death in anticoagulated patients with atrial fibrillation: Insights from the ARISTOTLE trial
Session: Poster Session 4 – Stroke Prevention
Aulin et al./Poster
Aug. 28,8:30-12:30
Poster Area Clinical outcomes in patients with atrial fibrillation and echocardiographic risk factors for stroke anticoagulated with apixaban or warfarin
Session: Poster Session 4 – Stroke Prevention
Vinereanu et al./ Poster Aug. 28,8:30-12:30
Poster Area Low apolipoprotein A1 is significantly associated with decreased risk of cardiovascular events in anticoagulated patients with atrial fibrillation: Insights from the ARISTOTLE trial
Session: Poster Session 4 – Atrial Fibrillation Obesity
Pol et al./Poster
Aug. 28,8:30-12:30
Poster AreaA novel biomarker-based risk score to predict death in patients with atrial fibrillation: Insights from the ARISTOTLE and RE-LY trials
Session: Stroke risk prediction in atrial fibrillation
Hijazi et al./Poster
Aug. 29,14:54-15:12
Valetta – Village 5 Real-World Data and Other AnalysesEffectiveness and safety of continued oral anticoagulation treatment beyond 1 year after venous thromboembolism in patients at intermediate risk: a nationwide propensity score weighted-cohort study
Session: After pulmonary embolism: optimising treatment and follow up
Johnsen et al./Oral Aug. 26,14:24-14:42
Rabat – Village 7 Real-world comparison of major bleeding risk associated with direct oral anticoagulants or warfarin in patients with non-valvular atrial fibrillation: a systematic review and network meta-analysis
Session: Poster Session 3 – Drug Treatment
Deitelzweig et al./Poster Aug. 27,14:00-18:00
Poster AreaEffectiveness and safety of apixaban versus warfarin among high-risk subgroups of non-valvular atrial fibrillation patients: a propensity score matched analysis
Session: Poster Session 4 – Stroke Prevention
Li et al./Poster
Aug. 28,8:30-12:30
Poster AreaPredictors of warfarin discontinuation or switching among non-valvular atrial fibrillation patients
Session: Poster Session 4 – Stroke Prevention
Luo et al./Poster
Aug. 28,8:30-12:30
Poster Area Effectiveness and safety of standard and lower dose apixaban compared to warfarin in non-valvular atrial fibrillation patients: a propensity score matched analysis
Session: Poster Session 4 – Stroke Prevention
Li et al./Poster
Aug. 28,8:30-12:30
Poster Area Stroke prevention: From policy to clinical practice in the U.S. and Europe
Session: Poster Session 4 – Cardiovascular risk factors in general population
Karnad et al./Poster
Aug. 28,8:30-12:30
Poster Area A changing landscape: temporal trends in incidence and characteristics of patients hospitalised with venous thromboembolism.
Session: Best Posters – Best Posters in acute pulmonary embolism
Johnsen et al./Poster Aug. 28, 14:00-18:00 Poster AreaRisk of major bleeding among non-valvular atrial fibrillation patients prescribed apixaban, dabigatran, rivaroxaban or warfarin in the U.S. Medicare population
Session: Poster Session 5 - Bleeding and LAA Occlusion
Trocio et al./Poster
Aug. 28,14:00-18:00
Poster AreaComparison of stroke and major bleeding risk of treatment with apixaban vs. rivaroxaban and dabigatran among elderly non-valvular atrial fibrillation patients in the United States
Session: Anticoagulation in Atrial Fibrillation
Deitelzweig et al./Rapid Fire Abstract Aug. 29,15:12-15:21
Agora 2About Eliquis
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 from multiple 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.
ELIQUIS Important Safety Information
WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA (A) Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases the risk of thrombotic events. If anticoagulation with ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.(B) Epidural or spinal hematomas may occur in patients treated with ELIQUIS who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
• use of indwelling epidural catheters
• concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
• a history of traumatic or repeated epidural or spinal punctures
• a history of spinal deformity or spinal surgery
• optimal timing between the administration of ELIQUIS and neuraxial procedures is not known
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated.CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
TEMPORARY INTERRUPTION FOR SURGERY AND OTHER INTERVENTIONS
DRUG INTERACTIONS
PREGNANCY CATEGORY B
Please see full Prescribing Information, including BOXED WARNINGS and Medication Guide, available at www.bms.com.
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 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. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
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, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @PfizerNews, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2016, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Pfizer Disclosure Notice
The information contained in this release is as of August 18, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Eliquis (apixaban), including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including, without limitation, the ability to meet anticipated clinical trial commencement and completion dates as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of Eliquis; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the SEC and available at www.sec.gov and www.pfizer.com.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170818005211/en/
Bristol-Myers SquibbMedia:Rob Perry, 407-492-4616rob.perry@bms.comorInvestors:Timothy Power, 609-252-7509timothy.power@bms.comorPfizer Inc.Media:Steven Danehy, 212-733-1538steven.danehy@pfizer.comorInvestors:Ryan Crowe, 212-733-8160ryan.crowe@pfizer.com
1 Year Bristol Myers Squibb Chart |
1 Month Bristol Myers Squibb Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions