Health Canada Approves Camzyos for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy

CAMZYOS TM   is the only Health Canada approved reversible cardiac myosin inhibitor indicated for the treatment of symptomatic obstructive hypertrophic cardiomyopathy of New York Heart Association (NYHA) Class II-III in adults.

Today, Bristol Myers Squibb Canada (BMS) announced Health Canada's approval of CAMZYOS TM (mavacamten capsules) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) of New York Heart Association (NYHA) Class II-III in adult patients. i Hypertrophic Cardiomyopathy (HCM) is a chronic disease where the heart's walls become thickened, making it harder for the heart to pump blood. CAMZYOS TM is the first Canadian-approved allosteric and selective cardiac myosin inhibitor that targets the underlying pathophysiology of oHCM. i

Bristol Myers Squibb Logo (CNW Group/Bristol Myers Squibb)

"Until now, the standard of care for patients has been to control the symptoms of obstructive HCM using drugs that were not designed for HCM. Patients often require invasive therapies," said Dr Rafik Tadros , Cardiologist, Montreal Heart Institute. "CAMZYOS TM has now brought an option that is specifically developed to treat the underlying pathophysiological mechanism of HCM and represents an important advance to improve functional capacity and quality of life in many patients."

About Hypertrophic Cardiomyopathy (HCM)

Hypertrophic cardiomyopathy (HCM) is the most common familial heart disease ii occurring in about 1 in 500 individuals and affects males and females of all ages and ethnic backgrounds. iii,iv Clinical presentation of hypertrophic cardiomyopathy during mid and late life is not uncommon with a diagnosis confirmed by demonstration of increased heart wall thickness of 1.5 cm or more, or more than 3 standard deviations from predicted. v

The most common subtype is obstructive hypertrophic cardiomyopathy (oHCM) vi which occurs when the left ventricular outflow tract (LVOT) becomes blocked or has reduced blood flow due to the heart walls becoming thick or stiff. vii Complications of the disease can include atrial fibrillation, stroke, heart failure, and in rare cases, sudden cardiac death. iii

"The patient experiences make it clear that obstructive hypertrophic cardiomyopathy is literally and figuratively one of the most devastating and heartbreaking rarely diagnosed conditions, with not only severe impact on daily life but also uncertainty of unforeseeable life-threatening episodes. We must do everything possible to assure every patient has access to timely, accurate diagnosis, optimal care, and best treatment available," said Durhane Wong-Rieger , Chair of the Canadian Heart Patient Alliance (CHPA). CHPA is a patient-led nonprofit umbrella organization of patients, families, health professionals and supporters with a collective vision of eliminating cardiovascular disease -- by taking action against the causes of cardiovascular disease, genetic, environmental, and lifestyle.

"Heart disease can develop at any age. Hypertrophic cardiomyopathy is often inherited and is the most common form of genetic heart disease. Knowing one's medical history and signs and symptoms is an important first step in receiving an accurate diagnosis to prevent serious complications, like heart failure," says Marc Bains , Co-founder, Vice President of the HeartLife Foundation and heart transplant recipient. The HeartLife Foundation is a patient-driven charity whose mission is to transform the quality of life for people living with heart failure by engaging, educating, and empowering a global community to create lasting solutions and build healthier lives.

"For more than 60 years, BMS has been working on treatments to fight against cardiovascular disease. We are determined to fundamentally change the approach by focussing on disease-modifying medicines that help patients in ways that were never possible before," said Troy André, General Manager, BMS Canada. "Today's approval is a testament to the importance of innovative medicines to help improve the lives of Canadians who are affected by this disease and are counting on us."

Clinical Data

The Canadian authorization was based on data from the Phase 3 EXPLORER-HCM trial which was a double-blind, randomized, placebo-controlled parallel group trial that enrolled a total of 251 adult patients with symptomatic (NYHA class II or III), oHCM. viii In EXPLORER HCM trial, 37% of patients achieved the primary endpoint a composite of functional capacity and symptoms compared to 17% of patients in the placebo group and all had greater improvement across the secondary endpoints at Week 30 in the CAMZYOS TM group compared to the placebo group. vii In the Phase 3 EXPLORER-HCM trial, serious adverse events were observed in 8.1% of mavacamten-treated patients and 8.6% of placebo-treated patients to Week 30. Overall safety and tolerability similar to placebo. ix

Important Safety Information i

CAMZYOS TM reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction. Echocardiogram assessments of LVEF and Left Ventricular Outflow tract (LVOT) gradient are required prior to, and regularly during, treatment with CAMZYOS TM . Initiation of CAMZYOS TM in patients with LVEF TM treatment if LVEF is TM with certain cytochrome P450 inhibitors and inducers may increase the risk of heart failure due to systolic dysfunction or may lead to a loss of therapeutic response. i

About Bristol Myers Squibb Canada Co.

Bristol Myers Squibb Canada Co. is an indirect wholly-owned subsidiary of Bristol Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Bristol Myers Squibb Canada Co. employs close to 300 people across the country. For more information, please visit https://www.bms.com/ca/en .

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.

For media requests please contact:

Rachel Yates
Corporate Affairs
Bristol Myers Squibb Canada
rachel.yates@bms.com

Tanvir Janmohamed
GCI Canada
613-404-3611
tanvir.janmohamed@gcicanada.com

_______________________________

i Canadian Product Monograph. Published November 9, 2022.

ii Maron BJ, Maron MS, Semsarian C. Genetics of hypertrophic cardiomyopathy after 20 years: clinical perspectives. J Am Coll Cardiol. 2012;60(8):705-715. https://pubmed.ncbi.nlm.nih.gov/22796258/

iii Maron BJ, Gardin JM, Flack JM, et al. Prevalence of hypertrophic cardiomyopathy in a general population of young adults. Echocardiographic analysis of 4111 subjects in the cardia study. Coronary artery risk development in (young) adults. Circulation 1995;92:785–9

iv Daniel L. Jacoby MD, Eugene C. DePasquale MD, William J. McKenna MD. Hypertrophic cardiomyopathy: diagnosis, risk strati cation and treatment. CMAJ, February 5, 2013, 185(2).

v Gupta RM, Weiner RB, Baggish AL, et al. Still a kid at heart: hypertrophic cardiomyopathy in the elderly. Circulation 2011; 124:857-63.

vi Christian Prinz, Dr. et al. The Diagnosis and Treatment of Hypertrophic Cardiomyopathy. 2011 Apr; 108(13): 209–215 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3078548/

vii Stanford Health Care. Hypertrophic cardiomyopathy. Accessed June 14, 2021. https://stanfordhealthcare.org/medical-conditions/blood-heart-circulation/hypertrophic-cardiomyopathy.html

viii Olivotto, I., Oreziak, A., Barriales-Villa, et al. Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (explorer-HCM): A randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet. Accessed October 18, 2022. https://www.thelancet.com/article/S0140-6736(20)31792-X/fulltext

ix https://www.thelancet.com/article/S0140-6736(20)31792-X/fulltext

SOURCE Bristol Myers Squibb

Cision View original content to download multimedia: https://www.newswire.ca/en/releases/archive/November2022/10/c4661.html

News Provided by Canada Newswire via QuoteMedia

BMY
The Conversation (0)
Corporate Employers Accused of Increasing Risk Of Pension Shortfalls in Violation of Employee Retirement Income Security Act of 1974

Corporate Employers Accused of Increasing Risk Of Pension Shortfalls in Violation of Employee Retirement Income Security Act of 1974

Lawsuits have been filed alleging that a number of large corporate employers have offloaded billions of dollars in pension obligations to Athene Annuity and Life Company andor Athene Annuity & Life Assurance Company of New York, subsidiaries of Athene Holding Ltd. (collectively, "Athene") in violation of ERISA. In addition to AT&T Inc. (NYSE: T), Lockheed Martin Corporation (NYSE: LMT), and Alcoa Corporation (NYSE: AA), against which lawsuits have already been filed, according to SEC filings andor Athene's public statements, Bristol-Myers Squibb Company (NYSE: BMY), Armstrong World Industries, Inc. (NYSE: AWI), ATI, Inc. (NYSE: ATI), Weyerhaeuser Company (NYSE: WY), and General Electric (NYSE: GE) have offloaded pension obligations to Athene.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Bristol Myers Squibb Reports First Quarter Financial Results for 2023

Bristol Myers Squibb Reports First Quarter Financial Results for 2023

  • Reports First Quarter Revenues of $11.3 Billion
  • Posts First Quarter GAAP Earnings Per Share of $1.07 and Non-GAAP EPS of $2.05; Includes Net Impact of ($0.01) Per Share for GAAP and Non-GAAP EPS Due to Acquired IPRD Charges and Licensing Income
  • Delivers Strong Revenue Growth of 8% from In-Line Products and New Product Portfolio; or 10% When Adjusted for Foreign Exchange
  • Further Advances Portfolio Renewal Strategy, Achieving Important Milestones Across Therapeutic Areas
  • Adjusts GAAP 2023 EPS Guidance; Affirms Non-GAAP Financial Guidance for 2023

Bristol Myers Squibb (NYSE:BMY) today reports results for the first quarter of 2023, which reflect robust in-line and new product portfolio growth, strong commercial execution and continued advancement of the product pipeline.

"Our strong execution resulted in double-digit revenue growth for our in-line products and new product portfolio," said Giovanni Caforio, M.D. , board chair and chief executive officer, Bristol Myers Squibb. "We continue to successfully execute against our key strategic priorities and meaningfully advance our portfolio renewal strategy, achieving important regulatory and clinical milestones that will benefit patients with serious unmet needs. We remain focused on commercial execution, progressing our pipeline and leveraging our strong financial foundation to invest in the next wave of innovation and deliver value to all of our stakeholders."

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Bristol Myers Squibb Announces Leadership Transition Plan

Bristol Myers Squibb Announces Leadership Transition Plan

Giovanni Caforio, MD, Bristol Myers Squibb Chairman and CEO, to Retire as CEO, Effective November 1, 2023; Will Continue as Executive Chairman of the Board

Christopher Boerner, PhD, EVP, Chief Commercialization Officer, Appointed EVP, Chief Operating Officer, Effective Immediately; to Succeed Giovanni Caforio, MD, as CEO, Effective November 1, 2023

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for CAMZYOS®  for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy

Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for CAMZYOS® for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy

If approved, CAMZYOS would be the first cardiac myosin inhibitor in Europe that specifically targets the source of obstructive HCM

Recommendation based on positive Phase 3 EXPLORER-HCM and VALOR-HCM trials demonstrating benefit in patients receiving CAMZYOS versus placebo

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Bristol Myers Squibb Strengthens Cell Therapy Capabilities by Adding New U.S. Manufacturing Facility for Viral Vector Production

Bristol Myers Squibb Strengthens Cell Therapy Capabilities by Adding New U.S. Manufacturing Facility for Viral Vector Production

Libertyville, Illinois facility bolsters long-term viral vector supply with multi-product, in-house viral vector production capabilities

Bristol Myers Squibb (NYSE: BMY) today announced expansion of its global cell therapy manufacturing network to enable in-house viral vector production through a U.S.-based manufacturing facility and its operations in Libertyville, Illinois, following the company's execution of an agreement with Novartis. The facility and its operations have capabilities to produce viral vector for both of Bristol Myers Squibb's CAR T cell therapies. This development advances the company's long-term ambitions in cell therapy.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Sirona Biochem (TSXV:SBM)

Sirona Biochem


Keep reading...Show less
Young female researcher working in a lab.

Radiopharmaceuticals Take Investors to the Forefront of Precision Oncology

Radiopharmaceuticals are emerging as one of the most promising innovations in modern medicine, particularly in precision oncology, and if recent billion-dollar investment deals are any indication, the potential for growth can be significant. Investors eyeing exposure to this emerging technology would benefit from a deeper understanding of the technology, its strategic applications and investment opportunities.

A groundbreaking technology in the field of oncology, radiopharmaceuticals combine radioactive substances with targeted molecules to revolutionise cancer detection and treatment. These innovative compounds are gaining significant attention due to their ability to deliver precise and targeted cancer therapies, minimising damage to healthy tissues while maximising therapeutic efficacy.

At their core, radiopharmaceuticals leverage the unique properties of radioactive isotopes, pairing them with molecules that have a high affinity for cancer cells. This combination allows for both diagnostic imaging and therapeutic applications, offering a level of precision previously unattainable in traditional cancer treatments.

Keep reading...Show less
Sirona Biochem Announces Publication of Groundbreaking Study on TFC-1326 Compound in the Journal of Cosmetic Dermatology

Sirona Biochem Announces Publication of Groundbreaking Study on TFC-1326 Compound in the Journal of Cosmetic Dermatology

Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) is proud to announce the publication of a pivotal research article in the prestigious Journal of Cosmetic Dermatology .

About the Study

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

AMGEN ANNOUNCES SENIOR EXECUTIVE RESEARCH APPOINTMENT

Howard Chang , M.D., Ph.D.,   Joins as Senior Vice President of Research and Chief Scientific Officer

Amgen (NASDAQ:AMGN) today announced that Howard Chang M.D., Ph.D., will join the company as senior vice president of Research, effective Dec. 16, 2024 . Chang will also assume the title and responsibility of serving as Amgen's chief scientific officer, reporting to Jay Bradner M.D., executive vice president of Research and Development.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Top 5 Life Science ETFs in 2024

Top 5 Life Science ETFs in 2024

Taking a position in a life science exchange-traded fund (ETF) provides exposure to a basket of stocks focused on the healthcare sector, while mitigating the risks of holding shares in a single company.

While ETFs provide diversification by their nature, fund managers often narrow down their offerings to follow a specific aspect of the market — for example, biotech or pharma. They also typically adjust the weight of ETF holdings to match movements in the life science industry in an effort to give investors the best possible returns.

There are many choices when it comes to life science ETFs, and to help investors understand their options, the Investing News Network has listed the top life science ETFs by year-on-year performance.

Keep reading...Show less
Radiopharm Theranostics

Australian Ethics Committee Approval to Expand PD-L1 Nanobody (RAD204) Phase 1 Trial in Multiple Tumor Types

Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce it has been granted Human Research Ethics Committee (HREC) approval to include participants with Programmed Death-Ligand 1 (PD-L1) positive Small Cell Lung Cancer (SCLC), Triple Negative Breast Cancer (TNBC), Melanoma, Head and Neck Cancer (HNSCC), and Endometrial Cancer, as part of its ongoing Phase 1 clinical trial of 177Lu-labelled RAD204 for the treatment of PD-L1 expressing cancers.
Keep reading...Show less

Latest Press Releases

Related News

×