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PRINCETON, N.J.--(BUSINESS WIRE)--Nov 2, 2022--
Bristol Myers Squibb (NYSE: BMY) today announced the presentation of research demonstrating the strength of the company’s cardiovascular franchise at the American Heart Association’s (AHA) annual Scientific Sessions, taking place in-person and virtually November 5-7, 2022. Findings from clinical, patient-reported outcomes and real-world studies will be presented across the cardiovascular portfolio. Notably, one abstract from the CAMZYOS ® (mavacamten) development program was accepted as a featured science presentation demonstrating advancements in the treatment of obstructive hypertrophic cardiomyopathy (HCM).
“The AHA annual Scientific Sessions is an important congress for us to share new data that is adding to the growing body of evidence demonstrating the continued positive, long-term impact our treatments are having for cardiovascular patients globally,” said Roland Chen, MD, senior vice president and head of cardiovascular development, Global Drug Development at Bristol Myers Squibb. “We continue to pursue the development of innovative, safe, effective and durable treatment options that improve patients’ lives, and are proud to showcase further analysis from our programs in obstructive hypertrophic cardiomyopathy and thrombosis.”
Key presentations include:
Summary of Presentations
Select Bristol Myers Squibb and Bristol Myers Squibb-Pfizer Alliance studies at the AHA Annual Scientific Sessions 2022 include:
Abstract Title
Primary Author
Type/#
Session Title
Time (CT)
Saturday, November 5, 2022
Mavacamten Treatment in Patients with Obstructive and Nonobstructive Hypertrophic Cardiomyopathy: A Pooled Safety Analysis of 5 Clinical Trials
Fermin, D
Poster - SA2183
HF.APS.P33 - Novel Drugs and Strategies for Heart Failure With Preserved Ejection Fraction
3:00 PM - 4:00 PM
Impact of Mavacamten on Artificial Intelligence Electrocardiographic Diagnosis of Hypertrophic Cardiomyopathy in the EXPLORER-HCM Trial
Siontis, K
Poster - SA2182
HF.APS.P33 - Novel Drugs and Strategies for Heart Failure With Preserved Ejection Fraction
3:00 PM - 4:00 PM
Sunday, November 6, 2022
Myosin Inhibition in Patients With Obstructive HCM Referred for Septal Reduction Therapy: 32-Week Active Blinded Crossover Results From VALOR-HCM Trial
Desai, M
FS.02 - New Insights - Cardiac Surgery
9:30 AM - 9:42 AM
The Association of Echocardiographic Parameters with Health Status in Patients with Obstructive Hypertrophic Cardiomyopathy. Insights from the EXPLORER-HCM Trial
Arnold, S
Oral -
QU.AOS.465 - Improving Cardiovascular Health Outcomes Through Real-World Science
10:06 AM - 10:16 AM
Effect of Mavacamten on Systolic Anterior Motion of the Mitral Valve and Mitral Regurgitation in Patients with Obstructive Hypertrophic Cardiomyopathy: Insights from the VALOR-HCM Study
Cremer, P
Moderated Poster - MP129
HF.MDP19 - New Insights From Clinical Trials: Pharmacologic Therapy for Heart Failure
10:30 AM - 10:35 AM
Predictors of Primary Non-Adherence in Patients With Nonvalvular Atrial Fibrillation Prescribed Oral Anticoagulants in the US*
Hines, DM
Poster - MP111
QU.MDP32 - Improving Cardiovascular Health: Prediction, Processes and Programs
12:00 PM - 12:05 PM
Effect of Mavacamten on Diastolic Function in Patients with Obstructive Hypertrophic Cardiomyopathy: Insights from the VALOR-HCM Study
Cremer, P
Oral -
IM.AOS.373 - Charles T. Dotter Memorial Lecture
4:18 PM - 4:28 PM
Monday, November 7, 2022
Racial Disparities and Geographic Variation in Anticoagulant Treatment Among Medicare Beneficiaries With Non-Valvular Atrial Fibrillation in the United States*
Kang, A
Oral -
EP.RFO32 - Out of Rhythm and Out of Step: Prevention and Management of Atrial Fibrillation
11:50 AM - 11:55 AM
Association Between Oral Anticoagulant Type and Hospital Readmission Rates Following Myocardial Infarction With Percutaneous Coronary Intervention in Patients With Nonvalvular Atrial Fibrillation*
Desai, N
Poster - MO4086
EA.APS.P278 - Broadening Our Understanding of Anticoagulation in the Setting of Atrial Fibrillation
1:45 PM - 2:45 PM
Benefits of Apixaban Over Warfarin are Preserved Independent of Warfarin Time in Therapeutic Range: Insights From the AUGUSTUS Trial*
Harrington, J
Poster -
EA.APS.P278 - Broadening Our Understanding of Anticoagulation in the Setting of Atrial Fibrillation
1:45 PM - 2:45 PM
Reduced versus Standard Dose Apixaban in Patients With Atrial Fibrillation and Acute Coronary Syndrome and/or Undergoing Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial*
Fudim, M
Poster - MO4087
EA.APS.P278 - Broadening Our Understanding of Anticoagulation in the Setting of Atrial Fibrillation
1:45 PM - 2:45 PM
*Sponsored by the Bristol Myers Squibb-Pfizer Alliance
About CAMZYOS (mavacamten)
CAMZYOS (mavacamten) is the first and only cardiac myosin inhibitor approved by the U.S. Food and Drug Administration (FDA) 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. 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 LVOT obstruction and improves cardiac filling pressures.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF HEART FAILURE
CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.
Echocardiogram 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.
Concomitant 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:
Because 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.
CONTRAINDICATIONS
CAMZYOS is contraindicated with concomitant use of:
WARNINGS AND PRECAUTIONS
Heart Failure
CAMZYOS 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.
Assess 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.
Asymptomatic LVEF reduction, intercurrent illnesses, and arrhythmias require additional dosing considerations.
Initiation 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 were excluded from EXPLORER-HCM. Concomitant use of CAMZYOS with disopyramide in combination with verapamil or diltiazem has been associated with left ventricular systolic dysfunction and heart failure symptoms in patients with obstructive HCM.
CYP 450 Drug Interactions Leading to Heart Failure or Loss of Effectiveness
CAMZYOS 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.
Advise 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.
CAMZYOS Risk Evaluation and Mitigation Strategy (REMS) Program
CAMZYOS 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:
Further information is available at www.CAMZYOSREMS.com or by telephone at 1-833-628-7367.
Embryo-Fetal Toxicity
CAMZYOS 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. CAMZYOS may reduce the effectiveness of combined hormonal contraceptives (CHCs). Advise patients using CHCs to use an alternative contraceptive method that is not affected by CYP 450 enzyme induction or to add nonhormonal contraception. Advise females of reproductive potential about the potential risk to the fetus with maternal exposure to CAMZYOS during pregnancy.
ADVERSE REACTIONS
In 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%).
Effects on Systolic Function
In 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.
DRUG INTERACTIONS
Potential for Other Drugs to Affect Plasma Concentrations of CAMZYOS
CAMZYOS 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.
Impact of Other Drugs on CAMZYOS:
Potential for CAMZYOS to Affect Plasma Concentrations of Other Drugs
CAMZYOS 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 where decreases in the plasma concentration of these drugs may reduce their activity.
Hormonal Contraceptives: Progestin and ethinyl estradiol are CYP3A4 substrates. Concomitant use of CAMZYOS may decrease exposures of ethinyl estradiol and progestin, which may lead to contraceptive failure or an increase in breakthrough bleeding. Advise patients to use a contraceptive method that is not affected by CYP 450 enzyme induction (e.g., intrauterine system) or add nonhormonal contraception (such as condoms) during concomitant use and for 4 months after the last dose of CAMZYOS.
Drugs That Reduce Cardiac Contractility
Expect additive negative inotropic effects of CAMZYOS and other drugs that reduce cardiac contractility. Avoid concomitant use of CAMZYOS with disopyramide in combination with verapamil or diltiazem. If 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.
SPECIFIC POPULATIONS
Pregnancy
CAMZYOS 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.
Lactation
The 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.
Females and Males of Reproductive Potential
Confirm 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. Use of CAMZYOS may reduce the effectiveness of CHCs. Advise patients using CHCs to use an alternative contraceptive method or add nonhormonal contraception.
Please see US Full Prescribing Information, including Boxed WARNING and Medication Guide.
About Eliquis
Eliquis ® 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.
ELIQUIS Important Safety Information
Indications
ELIQUIS 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.
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 isdiscontinued for a reason other than pathological bleeding or completion of acourse of therapy, consider coverage with another anticoagulant.
(B) Epidural or spinal hematomas may occur in patients treated withELIQUIS who are receiving neuraxial anesthesia or undergoing spinalpuncture. These hematomas may result in long-term or permanent paralysis.Consider these risks when scheduling patients for spinal procedures. Factorsthat can increase the risk of developing epidural or spinal hematomas in thesepatients include:
Monitor patients frequently for signs and symptoms of neurologicalimpairment. If neurological compromise is noted, urgent treatment isnecessary.
Consider the benefits and risks before neuraxial intervention in patientsanticoagulated or to be anticoagulated.
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
TEMPORARY INTERRUPTION FOR SURGERY AND OTHER INTERVENTIONS
DRUG INTERACTIONS
PREGNANCY
LACTATION
FEMALES AND MALES OF REPRODUCTIVE POTENTIAL
Please see U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, available at BMS.com.
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, Facebook and Instagram.
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.
Cautionary Statement Regarding Forward-Looking Statements
This 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 CAMZYOS ® (mavacamten) may not receive regulatory approval for the additional indication described in this release, that any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such product candidate for such additional indication 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, 2021, 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.
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CONTACT: Bristol Myers Squibb
Media Inquiries:
media@bms.com
Susan Francis
susan.francis@bms.com
609-529-0676
Investors:
Tim Power
timothy.power@bms.com
609-252-7509
KEYWORD: NEW JERSEY UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: BIOTECHNOLOGY HEALTH PHARMACEUTICAL CLINICAL TRIALS ONCOLOGY
SOURCE: Bristol Myers Squibb
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PUB: 11/02/2022 06:59 AM/DISC: 11/02/2022 06:59 AM
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