Health Canada Approves Camzyos^TM (mavacamten capsules) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy

MONTREAL, QUEBEC – November 10, 2022 – 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

“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 Informationⁱ

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 <55% is not recommended. Interrupt CAMZYOS^TM treatment if LVEF is <50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status. Concomitant use of CAMZYOS^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.

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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}

_{[1] https://www.thelancet.com/article/S0140-6736(20)31792-X/fulltext}