Bristol Myers Squibb Showcases the Continued Strength of its Cardiovascular Portfolio with New Clinical and Real-World Data at American Heart Association Scientific Sessions 2024

Business Wire11-11

Real-world and long-term extension data, including updated results from post-launch evaluation of REMS Program, bolster growing body of evidence supporting the efficacy and safety profile of CAMZYOS® ...

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}\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nBristol Myers Squibb Showcases the Continued Strength of its Cardiovascular Portfolio with New Clinical and Real-World Data at American Heart Association Scientific Sessions 2024\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-11-11 19:59 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/bristol-myers-squibb-showcases-continued-115900004.html><strong>Business Wire</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Real-world and long-term extension data, including updated results from post-launch evaluation of REMS Program, bolster growing body of evidence supporting the efficacy and safety profile of CAMZYOS® ...</p>\n\n<a href=\"https://finance.yahoo.com/news/bristol-myers-squibb-showcases-continued-115900004.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU1430594728.SGD","symbol_name":"Eastspring Investments - Global Low Volatility Equity AS SGD","start_time":0,"source_url":"https://finance.yahoo.com/news/bristol-myers-squibb-showcases-continued-115900004.html","article_id":"2482785503","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/3q66LDeE84gayQNr2.eZZA--~B/aD0yMDY7dz0xNDk3O2FwcGlkPXl0YWNoeW9u/https://media.zenfs.com/en/business-wire.com/4c2453f18c560c3bc5bcc5e671d1bc51"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2482785503","pubTimestamp":1731326340,"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"Real-world and long-term extension data, including updated results from post-launch evaluation of REMS Program, bolster growing body of evidence supporting the efficacy and safety profile of CAMZYOS . \"We look forward to AHA where we will share data that build on our 70-year legacy of pioneering cardiovascular research and delivering paradigm-changing medicines to address the growing burden of cardiovascular disease,\" said Roland Chen, MD, senior vice president and head of Immunology, Cardiovascular & Neuroscience  Development at Bristol Myers Squibb. \"Data to be presented at the meeting highlight our commitment to improving clinical outcomes for patients around the world by delivering transformational therapies, like CAMZYOS, the first and only approved cardiac myosin inhibitor.\". Abstracts sponsored by Bristol Myers Squibb, the BMS-Pfizer Alliance and the BMS-Johnson & Johnson Collaboration to be presented at AHA Scientific Sessions 2024 can be found below. 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New analyses include updated results from the nearly two-year post-launch evaluation of the CAMZYOS® (mavacamten) Risk Evaluation and Mitigation Strategy (REMS) Program and real-world and long-term extension data reinforcing the efficacy and safety profile of CAMZYOS, as well as data on behalf of the BMS-Pfizer Alliance on ELIQUIS® (apixaban) and the BMS-Johnson & Johnson Collaboration on milvexian.\n\"We look forward to AHA where we will share data that build on our 70-year legacy of pioneering cardiovascular research and delivering paradigm-changing medicines to address the growing burden of cardiovascular disease,\" said Roland Chen, MD, senior vice president and head of Immunology, Cardiovascular & Neuroscience (ICN) Development at Bristol Myers Squibb. \"Data to be presented at the meeting highlight our commitment to improving clinical outcomes for patients around the world by delivering transformational therapies, like CAMZYOS, the first and only approved cardiac myosin inhibitor.\"\nWith inclusion in both the ESC and AHA/ACC clinical guidelines as a recommended option for when symptoms persist after first-line therapy, CAMZYOS is a standard of care for NYHA class II-III symptomatic obstructive hypertrophic cardiomyopathy (oHCM).\nResearch to be presented at the meeting supports the growing body of evidence of CAMZYOS, including compliance with the REMS Program. These data include:\n\nAn updated analysis of results from the post-launch evaluation of the CAMZYOS REMS Program spanning nearly 2-years (22-months).\nA featured science presentation of the 128-week analysis (nearly 2.5 years) of the VALOR-HCM long-term study analyzing the efficacy and safety profile of CAMZYOS in reducing patient eligibility and/or decision to proceed with septal reduction therapy (SRT) in patients with symptomatic oHCM.\nNew real-world evidence on CAMZYOS’ long-term effectiveness and safety profile, including data from MARVEL-HCM—the largest observational study on CAMZYOS’ effectiveness—and from COLLIGO-HCM, a real-world study examining racially diverse patients and those with higher disease burden than typically seen in clinical trials.\n\nAbstracts sponsored by Bristol Myers Squibb, the BMS-Pfizer Alliance and the BMS-Johnson & Johnson Collaboration to be presented at AHA Scientific Sessions 2024 can be found below. Complete abstracts may be accessed online here. Visit this page on BMS.com for more information on Bristol Myers Squibb’s scientific approach and resources on cardiovascular diseases.\n\n\n\nAbstract Title\nPrimary Author\nType\nSession Title\nDate/Time (CST)\n\n\nCAMZYOS (mavacamten)\n\n\nInvestigating the natural history and risk factors underlying deterioration in early-stage hypertrophic cardiomyopathy: Findings from SOLENOID\nBradlow, W.\nModerated Poster\nBulking Up: The Latest in Hypertrophic Cardiomyopathy\nSaturday, Nov. 16, 3:10 PM – 3:15 PM\n\n\nBeta blockers and calcium channel blockers in asymptomatic patients with hypertrophic cardiomyopathy: Prevalence, discontinuation, and effectiveness\nBradlow, W.\nModerated Poster\nData to Discovery: Novel Methods in Cardiovascular Outcomes Research\nSaturday, Nov. 16,3:50 PM – 3:55 PM\n\n\nIdentification of obstructive and non-obstructive hypertrophic cardiomyopathy patients using natural language processing in a large integrated healthcare system\nSolomon, M.\nModerated Poster\nAdvances in Identification and Management of Hypertrophic Cardiomyopathy – MDP964\nSunday, Nov. 17, 9:30 AM – 9:35 AM\n\n\nReal-world treatment patterns of mavacamten and associated background therapies in patients with obstructive hypertrophic cardiomyopathy (HCM) in the United States\nHan, X.\nTraditional Poster\nEmerging Interventions for Heart Failure – Su2191\nSunday, Nov. 17, 3:15 PM – 4:15 PM\n\n\nMavacamten: Real-world experience from 22 months of the Risk Evaluation and Mitigation Strategy (REMS) Program\nDesai, M.\nOral Presentation\nFrom Bench to Bedside in Heart Failure\nMonday, Nov. 18, 9:00 AM – 9:10 AM\n\n\nMavacamten treatment in patients with obstructive HCM referred for septal reduction therapy: 128-week results from VALOR-HCM trial\nDesai, M.\nOral Featured Science Presentation\nFeatured Science: Amyloid, Hypertrophic, and Danon Cardiomyopathies: Targeted Therapies and Specific Populations\nMonday, Nov. 18, 9:57 AM – 10:05 AM\n\n\nLong-term effectiveness and safety of mavacamten in a real-world, multi-center, global study: Preliminary results of COLLIGO-HCM from a diverse cohort in the United States\nMacNamara, J.\nModerated Poster\nHypertrophy and Heart Failure – MDP1368\nMonday, Nov. 18,11:50 AM – 11:55 AM\n\n\nEarly insights on mavacamten usage in Canada: A retrospective cohort of the patient support program\nOng, K.\nModerated Poster\nHypertrophy and Heart Failure – MDP1369\nMonday, Nov. 18,12:00 PM – 12:05 PM\n\n\nReal-world long-term effectiveness of mavacamten in patients with symptomatic obstructive hypertrophic cardiomyopathy: A multicenter observational study (MARVEL-HCM)\nAbraham, T.\nModerated Poster\nHypertrophy and Heart Failure – MDP1370\nMonday, Nov. 18,12:10 PM – 12:15 PM\n\n\nIntegrated safety and tolerability of mavacamten treatment over 5 years in patients with obstructive hypertrophic cardiomyopathy\nOwens, A.\nModerated Poster\nHypertrophy and Heart Failure – MDP1371\nMonday, Nov. 18,12:20 PM – 12:25 PM\n\n\nMavacamten in adolescent patients with symptomatic obstructive hypertrophic cardiomyopathy: Design of the Phase 3 SCOUT-HCM trial\nRossano, J.\nTraditional Poster\nPediatric Heart Failure, Transplantation, and Long-Term Outcomes – Mo2025\nMonday, Nov. 18,1:30 PM – 2:30 PM\n\n\nELIQUIS (apixaban) – Sponsored by the Bristol Myers Squibb-Pfizer Alliance\n\n\nUnderstanding medication adherence to oral anticoagulants in atrial fibrillation management: Patient and provider perspectives in a mixed methods study\nWendt, S.\nModerated Poster\nData to Discovery: Novel Methods in Cardiovascular Outcomes Research\nMonday, Nov. 18,10:30 AM – 11:30 AM\n\n\nMilvexian – Sponsored by the Bristol Myers Squibb-Johnson & Johnson Collaboration\n\n\nCurrent oral anticoagulation use among patients with atrial fibrillation and risk factors associated with inadequate treatments: A report from a UK population cohort study\nKang, A.\nPoster presentation\nMedications in Motion: Innovating Pharmacotherapy for Enhanced Treatment Outcomes\nMonday, Nov. 18,1:30 PM – 2:30 PM\n\n\n\nAbout CAMZYOS® (mavacamten)\nCAMZYOS® (mavacamten) is the first and only cardiac myosin inhibitor approved in the U.S., indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms, and in the European Union, indicated for the treatment of symptomatic (NYHA, class II-III) obstructive HCM in adult patients. It has also received regulatory approvals in countries and regions across five continents. CAMZYOS is an allosteric and reversible inhibitor selective for cardiac myosin. CAMZYOS modulates the number of myosin heads that can enter \"on actin\" (power-generating) states, thus reducing the probability of force-producing (systolic) and residual (diastolic) cross-bridge formation. Excess myosin actin cross-bridge formation and dysregulation of the super-relaxed state are mechanistic hallmarks of HCM. CAMZYOS shifts the overall myosin population towards an energy-sparing, recruitable, super-relaxed state. In HCM patients, myosin inhibition with CAMZYOS reduces dynamic left ventricular outflow tract (LVOT) obstruction and improves cardiac filling pressures.\nIMPORTANT SAFETY INFORMATION\nWARNING: RISK OF HEART FAILURE\nCAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.\nEchocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Interrupt CAMZYOS if LVEF is <50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.\nConcomitant use of CAMZYOS with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of CAMZYOS is contraindicated with the following:\n\nModerate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors\nModerate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers\n\nBecause of the risk of heart failure due to systolic dysfunction, CAMZYOS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CAMZYOS REMS PROGRAM.\nCONTRAINDICATIONS\nCAMZYOS is contraindicated with concomitant use of:\n\nModerate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors\nModerate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers\n\nWARNINGS AND PRECAUTIONS\nHeart Failure\nCAMZYOS reduces systolic contraction and can cause heart failure or totally block ventricular function. Patients who experience a serious intercurrent illness (e.g., serious infection) or arrhythmia (e.g., atrial fibrillation or other uncontrolled tachyarrhythmia) are at greater risk of developing systolic dysfunction and heart failure.\nAssess the patient’s clinical status and LVEF prior to and regularly during treatment and adjust the CAMZYOS dose accordingly. New or worsening arrhythmia, dyspnea, chest pain, fatigue, palpitations, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide (NT-proBNP) may be signs and symptoms of heart failure and should also prompt an evaluation of cardiac function.\nAsymptomatic LVEF reduction, intercurrent illnesses, and arrhythmias require additional dosing considerations.\nInitiation of CAMZYOS in patients with LVEF <55% is not recommended. Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited.\nCYP 450 Drug Interactions Leading to Heart Failure or Loss of Effectiveness\nCAMZYOS is primarily metabolized by CYP2C19 and CYP3A4 enzymes. Concomitant use of CAMZYOS and drugs that interact with these enzymes may lead to life-threatening drug interactions such as heart failure or loss of effectiveness.\nAdvise patients of the potential for drug interactions, including with over-the-counter medications (such as omeprazole, esomeprazole, or cimetidine). Advise patients to inform their healthcare provider of all concomitant products prior to and during CAMZYOS treatment.\nCAMZYOS Risk Evaluation and Mitigation Strategy (REMS) Program\nCAMZYOS is only available through a restricted program called the CAMZYOS REMS Program because of the risk of heart failure due to systolic dysfunction. Notable requirements of the CAMZYOS REMS Program include the following:\n\nPrescribers must be certified by enrolling in the REMS Program.\nPatients must enroll in the REMS Program and comply with ongoing monitoring requirements.\nPharmacies must be certified by enrolling in the REMS Program and must only dispense to patients who are authorized to receive CAMZYOS.\nWholesalers and distributors must only distribute to certified pharmacies.\n\nFurther information is available at www.CAMZYOSREMS.com or by telephone at 1-833-628-7367.\nEmbryo-Fetal Toxicity\nCAMZYOS may cause fetal toxicity when administered to a pregnant female, based on animal studies. Confirm absence of pregnancy in females of reproductive potential prior to treatment and advise patients to use effective contraception during treatment with CAMZYOS and for 4 months after the last dose. CHCs containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS. However, CAMZYOS may reduce the effectiveness of combined hormonal contraceptives (CHC). If these CHCs are used, advise patients to add nonhormonal contraception (such as condoms) during concomitant use and for 4 months after the last dose of CAMZYOS.\nADVERSE REACTIONS\nIn the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the CAMZYOS group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%). There were no new adverse reactions identified in VALOR-HCM.\nEffects on Systolic Function\nIn the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. In the EXPLORER-HCM trial, 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS.\nDRUG INTERACTIONS\nPotential for Other Drugs to Affect Plasma Concentrations of CAMZYOS\nCAMZYOS is primarily metabolized by CYP2C19 and to a lesser extent by CYP3A4 and CYP2C9. Inducers and inhibitors of CYP2C19 and moderate to strong inhibitors or inducers of CYP3A4 may affect the exposures of CAMZYOS.\nImpact of Other Drugs on CAMZYOS:\n\nModerate to Strong CYP2C19 Inhibitors or Strong CYP3A4 Inhibitors: Concomitant use increases CAMZYOS exposure, which may increase the risk of heart failure due to systolic dysfunction. Concomitant use is contraindicated.\nModerate to Strong CYP2C19 Inducers or Moderate to Strong CYP3A4 Inducers: Concomitant use decreases CAMZYOS exposure, which may reduce CAMZYOS’ efficacy. The risk of heart failure due to systolic dysfunction may increase with discontinuation of these inducers as the levels of induced enzyme normalizes. Concomitant use is contraindicated.\nWeak CYP2C19 Inhibitors or Moderate CYP3A4 Inhibitors: Concomitant use with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor increases CAMZYOS exposure, which may increase the risk of adverse drug reactions. Initiate CAMZYOS at the recommended starting dose of 5 mg orally once daily in patients who are on stable therapy with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Reduce dose of CAMZYOS by one level (i.e., 15 to 10 mg, 10 to 5 mg, or 5 to 2.5 mg) in patients who are on CAMZYOS treatment and intend to initiate a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Schedule clinical and echocardiographic assessment 4 weeks after inhibitor initiation, and do not up-titrate CAMZYOS until 12 weeks after inhibitor initiation. Avoid initiation of concomitant weak CYP2C19 and moderate CYP3A4 inhibitors in patients who are on stable treatment with 2.5 mg of CAMZYOS because a lower dose is not available.\n\nPotential for CAMZYOS to Affect Plasma Concentrations of Other Drugs\nCAMZYOS is an inducer of CYP3A4, CYP2C9, and CYP2C19. Concomitant use with CYP3A4, CYP2C19, or CYP2C9 substrates may reduce plasma concentration of these drugs. Closely monitor when CAMZYOS is used in combination with CYP3A4, CYP2C19, or CYP2C9 substrates unless otherwise recommended in the Prescribing Information.\nCertain Combined Hormonal Contraceptives (CHC): Progestin and ethinyl estradiol are CYP3A4 substrates. Concomitant use of CAMZYOS may decrease exposures of certain progestins, which may lead to contraceptive failure. CHCs containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS, but if other CHCs are used, advise patients to add nonhormonal contraception (such as condoms) during concomitant use and for 4 months after the last dose of CAMZYOS.\nDrugs That Reduce Cardiac Contractility\nExpect additive negative inotropic effects of CAMZYOS and other drugs that reduce cardiac contractility. Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited.\nIf concomitant therapy with a negative inotrope is initiated, or if the dose of a negative inotrope is increased, monitor LVEF closely until stable doses and clinical response have been achieved.\nSPECIFIC POPULATIONS\nPregnancy\nCAMZYOS may cause fetal harm when administered to a pregnant female. Advise pregnant females about the potential risk to the fetus with maternal exposure to CAMZYOS during pregnancy. There is a pregnancy safety study for CAMZYOS. If CAMZYOS is administered during pregnancy, or if a patient becomes pregnant while receiving CAMZYOS or within 4 months after the last dose of CAMZYOS, healthcare providers should report CAMZYOS exposure by contacting Bristol Myers Squibb at 1-800-721-5072 or www.bms.com.\nLactation\nThe presence of CAMZYOS in human or animal milk, the drug’s effects on the breastfed infant, or the effects on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CAMZYOS and any potential adverse effects on the breastfed child from CAMZYOS or from the underlying maternal condition.\nFemales and Males of Reproductive Potential\nConfirm absence of pregnancy in females of reproductive potential prior to initiation of CAMZYOS. Advise females of reproductive potential to use effective contraception during treatment with CAMZYOS and for 4 months after the last dose. CHCs containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS. However, CAMZYOS may reduce the effectiveness of certain other combined hormonal contraceptives (CHC). If these CHCs are used, advise patients to add nonhormonal contraception (such as condoms) during concomitant use and for 4 months after the last dose of CAMZYOS.\nPlease see U.S. Full Prescribing Information, including Boxed WARNING and Medication Guide.\nAbout ELIQUIS ® (apixaban)\nELIQUIS® 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 non-valvular 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 continues to be developed and commercialized by The Bristol Myers Squibb-Pfizer Alliance.\nELIQUIS Important Safety Information\nIndications\nELIQUIS is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. ELIQUIS is indicated 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. ELIQUIS is indicated for the treatment of DVT and PE, and to reduce the risk of recurrent DVT and PE following initial therapy.\nImportant Safety Information\nWARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA\n(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.\n(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:\n\nuse of indwelling epidural catheters\nconcomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants\na history of traumatic or repeated epidural or spinal punctures\na history of spinal deformity or spinal surgery\noptimal timing between the administration of ELIQUIS and neuraxial procedures is not known\n\nMonitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.\nConsider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated.\nCONTRAINDICATIONS\n\nActive pathological bleeding\nSevere hypersensitivity reaction to ELIQUIS (e.g., anaphylactic reactions)\n\nWARNINGS AND PRECAUTIONS\n\nIncreased Risk of Thrombotic Events after Premature Discontinuation: Premature discontinuation of any oral anticoagulant, including ELIQUIS, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from ELIQUIS to warfarin in clinical trials in atrial fibrillation patients. If ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.\nBleeding Risk: ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal, bleeding.\nConcomitant use of drugs affecting hemostasis increases the risk of bleeding, including aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, and NSAIDs.\nAdvise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room. Discontinue ELIQUIS in patients with active pathological hemorrhage.\nThe anticoagulant effect of apixaban can be expected to persist for at least 24 hours after the last dose (i.e., about two half-lives). An agent to reverse the anti-factor Xa activity of apixaban is available. Please visit www.andexxa.com for more information on availability of a specific reversal agent.\nSpinal/Epidural Anesthesia or Puncture: Patients treated with ELIQUIS undergoing spinal/epidural anesthesia or puncture may develop an epidural or spinal hematoma which can result in long-term or permanent paralysis.The risk of these events may be increased by the postoperative use of indwelling epidural catheters or the concomitant use of medicinal products affecting hemostasis. Indwelling epidural or intrathecal catheters should not be removed earlier than 24 hours after the last administration of ELIQUIS. The next dose of ELIQUIS should not be administered earlier than 5 hours after the removal of the catheter. The risk may also be increased by traumatic or repeated epidural or spinal puncture. If traumatic puncture occurs, delay the administration of ELIQUIS for 48 hours.Monitor patients frequently and if neurological compromise is noted, urgent diagnosis and treatment is necessary. Physicians should consider the potential benefit versus the risk of neuraxial intervention in ELIQUIS patients.\nProsthetic Heart Valves: The safety and efficacy of ELIQUIS have not been studied in patients with prosthetic heart valves and is not recommended in these patients.\nAcute PE in Hemodynamically Unstable Patients or Patients who Require Thrombolysis or Pulmonary Embolectomy: Initiation of ELIQUIS is not recommended as an alternative to unfractionated heparin for the initial treatment of patients with PE who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.\nIncreased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome (APS): Direct-acting oral anticoagulants (DOACs), including ELIQUIS, are not recommended for use in patients with triple-positive APS. For patients with APS (especially those who are triple positive [positive for lupus anticoagulant, anticardiolipin, and anti–beta 2-glycoprotein I antibodies]), treatment with DOACs has been associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.\n\nADVERSE REACTIONS\n\nThe most common and most serious adverse reactions reported with ELIQUIS were related to bleeding.\n\nTEMPORARY INTERRUPTION FOR SURGERY AND OTHER INTERVENTIONS\n\nELIQUIS should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. ELIQUIS should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be noncritical in location and easily controlled. Bridging anticoagulation during the 24 to 48 hours after stopping ELIQUIS and prior to the intervention is not generally required. ELIQUIS should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established.\n\nDRUG INTERACTIONS\n\nCombined P-gp and Strong CYP3A4 Inhibitors: Inhibitors of P-glycoprotein (P-gp) and cytochrome P450 3A4 (CYP3A4) increase exposure to apixaban and increase the risk of bleeding. For patients receiving ELIQUIS doses of 5 mg or 10 mg twice daily, reduce the dose of ELIQUIS by 50% when ELIQUIS is coadministered with drugs that are combined P-gp and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or ritonavir). In patients already taking 2.5 mg twice daily, avoid coadministration of ELIQUIS with combined P-gp and strong CYP3A4 inhibitors.Clarithromycin Although clarithromycin is a combined P-gp and strong CYP3A4 inhibitor, pharmacokinetic data suggest that no dose adjustment is necessary with concomitant administration with ELIQUIS.\nCombined P-gp and Strong CYP3A4 Inducers: Avoid concomitant use of ELIQUIS with combined P-gp and strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort) because such drugs will decrease exposure to apixaban.\nAnticoagulants and Antiplatelet Agents: Coadministration of antiplatelet agents, fibrinolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding. APPRAISE-2, a placebo-controlled clinical trial of apixaban in high-risk post-acute coronary syndrome patients treated with aspirin or the combination of aspirin and clopidogrel, was terminated early due to a higher rate of bleeding with apixaban compared to placebo.\n\nPREGNANCY\n\nThe limited available data on ELIQUIS use in pregnant women are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse developmental outcomes. Treatment may increase the risk of bleeding during pregnancy and delivery, and in the fetus and neonate.\n  \nLabor or delivery: ELIQUIS use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas. Consider use of a shorter acting anticoagulant as delivery approaches.\n\n\nLACTATION\n\nBreastfeeding is not recommended during treatment with ELIQUIS.\n\nFEMALES AND MALES OF REPRODUCTIVE POTENTIAL\n\nFemales of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. The risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants including ELIQUIS should be assessed in these patients and those with abnormal uterine bleeding.\n\nPlease see U.S. Full Prescribing Information, including Boxed WARNINGS, available at BMS.com.\nAbout the Bristol Myers Squibb-Pfizer Collaboration\nThe Bristol Myers Squibb-Pfizer Alliance (the Alliance) is committed to driving education and awareness about atrial fibrillation and deep vein thrombosis (DVT) and/or pulmonary embolism (PE). With long-standing cardiovascular leadership, global scale and expertise in this field, the Alliance strives to implement global, research-driven approaches to illuminate and address the unmet needs around strokes related to non-valvular atrial fibrillation, which are often fatal or debilitating. Through collaborations with non-profit organizations, the Alliance aims to provide patients, healthcare professionals and decision makers with the information they need to understand and take appropriate action on risk factors associated with stroke and other cardiovascular conditions.\nAbout Milvexian*\nMilvexian is an investigational oral, highly selective Factor XIa (FXIa) inhibitor, part of a new class of anticoagulants in development aimed at preventing harmful clotting that restricts blood flow (thrombosis) while preserving the normal clotting process (hemostasis). As a result, milvexian could potentially reduce major cardiovascular events due to harmful clotting without significantly increasing the risk of bleeding. It is currently being studied in the Phase 3 Librexia program, the most comprehensive FXIa clinical development program to date, for the prevention and treatment of major thrombotic conditions.\n*Milvexian is an investigational agent and has not been approved for use in any country, for any indication.\nAbout the Bristol Myers Squibb-Johnson & Johnson Collaboration\nBristol Myers Squibb and Johnson & Johnson, two unsurpassed leaders in cardiovascular care, are determined to close the gap in unmet needs in thrombosis management by overcoming the limits of today’s treatments. The collaboration to develop and commercialize milvexian aims to leverage the combined scientific expertise and world-class commercial capabilities of each company, to improve patient outcomes. The alliance is uniquely equipped to deliver on the promise of FXIa inhibitors and is working diligently to ensure cutting-edge safe and effective treatment options are available for patients.\nAbout Bristol Myers Squibb\nBristol 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, X, YouTube, Facebook and Instagram.\nCautionary Statement Regarding Forward-Looking Statements\nThis press release contains \"forward-looking statements\" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that milvexian may not receive regulatory approval for the indications described in this release, any marketing approvals, if granted, may have significant limitations on their use, and, whether CAMZYOS (mavacamten), ELIQUIS (apixaban) or milvexian, if approved, for such indications described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.\ncorporatefinancial-news\nView source version on businesswire.com: https://www.businesswire.com/news/home/20241108701311/en/\nContacts\nBristol Myers Squibb Media Inquiries: media@bms.com Investors: investor.relations@bms.com","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.1","shortVersion":"4.29.1","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2482785503"}