CAMZYOSTM 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.
MONTREAL, Nov. 10,
2022 /CNW/ - Today, Bristol Myers Squibb Canada (BMS)
announced Health Canada's approval
of CAMZYOSTM (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. CAMZYOSTM 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. "CAMZYOSTM 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 diseaseii 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 CAMZYOSTM 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
CAMZYOSTM 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 CAMZYOSTM. Initiation of
CAMZYOSTM in patients with LVEF <55% is not
recommended. Interrupt CAMZYOSTM treatment if LVEF
is <50% at any visit or if the patient experiences heart failure
symptoms or worsening clinical status. Concomitant use of
CAMZYOSTM 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
_______________________________
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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/
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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
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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).
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v Gupta RM,
Weiner RB, Baggish AL, et al. Still a kid at heart: hypertrophic
cardiomyopathy in the elderly. Circulation 2011;
124:857-63.
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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/
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vii Stanford
Health Care. Hypertrophic cardiomyopathy. Accessed June 14, 2021.
https://stanfordhealthcare.org/medical-conditions/blood-heart-circulation/hypertrophic-cardiomyopathy.html
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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
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ix
https://www.thelancet.com/article/S0140-6736(20)31792-X/fulltext
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SOURCE Bristol Myers Squibb