- BRENZYS® is a biosimilar biologic drug authorized
based on its similarity to ENBREL®, which is already
approved for use in Canada.1
- Approximately one million people in Canada live with psoriasis,2 and
between 10 and 30% of people with psoriasis will develop psoriatic
arthritis.3
KIRKLAND, QC, Sept. 15, 2020 /CNW/ - Merck Canada Inc., an
affiliate of Merck & Co., Inc., known as MSD outside
the United States and
Canada, announced today that Health Canada has approved
BRENZYS®, a TNF-inhibitor, for four new indications:
- Adult patients with chronic moderate to severe plaque psoriasis
(PsO) who are candidates for systemic therapy or phototherapy
- Pediatric patients ages 4 to 17 years with chronic severe PsO
who are candidates for systemic therapy or phototherapy
- Reducing signs and symptoms, inhibiting the progression of
structural damage of active arthritis and improving physical
function in adult patients with psoriatic arthritis (PsA)
- Reducing signs and symptoms of moderately to severely active
polyarticular juvenile idiopathic arthritis (JIA) in patients aged
4 to 17 years who have had an inadequate response to one or more
disease-modifying antirheumatic drugs (DMARDs). 4
BRENZYS® is a type of protein called a tumour
necrosis factor (TNF) blocker that blocks the action of a substance
the body makes called TNF-alpha. TNF-alpha is made by the body's
immune system.5 People with immune diseases like JIA,
PsA and PsO have too much TNF-alpha in their bodies, which can
cause inflammation and lead to painful, swollen joints and raise
thick, red, scaly patches ("psoriatic skin lesions") that can
appear anywhere on the body.6 It can reduce the amount
of TNF in the body to normal levels, helping to treat joint damage
and psoriatic skin conditions. 7
An estimated one million Canadians live with
psoriasis,8 and between 10 and 30% of these patients
will develop psoriatic arthritis.9 Plaque Psoriasis is
an inflammatory disease that affects the skin and can cause
psoriatic skin lesions that can appear anywhere on the
body.10 About 80% to 90% of people with psoriasis have
plaque psoriasis, the most common type of psoriasis.11
PsA is usually seen in patients with PsO and affects both the
joints and the skin.12 JIA is an inflammatory
disease that affects the joints in the body and is the most common
type of arthritis in children under the age of 16.13
Approximately 10,000 children and teens live with arthritis in
Canada.14
"Merck is committed to providing Canadians with more therapeutic
choices for patients and their treaters," says AnnA Van Acker, President, Merck Canada.
"BRENZYS® adds to Merck's portfolio of treatments for
dermatological and inflammatory immune diseases and can help
improve quality of life for patients living with psoriasis,
psoriatic arthritis or juvenile idiopathic arthritis, as well as
rheumatoid arthritis and ankylosing spondylitis."
About BRENZYS®
BRENZYS® is a biosimilar biologic drug
(biosimilar)15 and authorized based on its similarity to
ENBREL®, which is already approved for use for PsO, PsA
and JIA in Canada.16 A
biosimilar is a biologic drug that is highly similar to a biologic
drug already authorized for sale.17 Biosimilars are
assessed and approved by Health Canada against the same meticulous
standards used to ensure the quality, efficacy and safety of all
other biologic drugs.18 Biosimilars provide patients
more treatment options to help manage their disease and
symptoms.
In addition to its use for the treatment of JIA, PsO and PsA,
BRENZYS® was first approved by Health Canada in 2016 for
the treatment of moderate-to-severe rheumatoid arthritis (RA) in
adults and ankylosing spondylitis (AS).19 It is
administered by an injection under the skin and should be used
under the guidance and supervision of a physician.20
Clinical efficacy and safety studies have been conducted in
patients with rheumatoid arthritis to demonstrate clinical
comparability between BRENZYS® and ENBREL®.
The extrapolation of these data to support uses of
BRENZYS® in ankylosing spondylitis is based on the
demonstrated comparability, in terms of product quality,
non-clinical, human pharmacokinetic and clinical characteristics.
Randomized clinical trials have not been conducted to compare
BRENZYS® to Enbrel® in patients with
psoriatic arthritis, ankylosing spondylitis, plaque psoriasis,
juvenile idiopathic arthritis and pediatric
psoriasis.21
The most common expected adverse reactions with
BRENZYS® are infections, injection site reactions and
headaches. It should not be administered to patients with or at
risk of sepsis. BRENZYS® contains a Boxed Warning to
alert health care professionals and patients about an increased
risk of serious infections including tuberculosis and infections
caused by bacteria, viruses or fungi that have spread throughout
their body. The Boxed Warning also notes that malignancies,
sometimes fatal, have been reported in children and teenage
patients who started using TNF-blocking agents, including
etanercept, at less than 18 years of age.22
About Merck
For more than 125 years, Merck, known as MSD outside of
the United States and Canada, has been inventing for life, bringing
forward medicines and vaccines for many of the world's most
challenging diseases in pursuit of our mission to save and improve
lives. We demonstrate our commitment to patients and population
health by increasing access to health care through far-reaching
policies, programs and partnerships. Today, Merck continues to be
at the forefront of research to prevent and treat diseases that
threaten people and animals — including cancer, infectious diseases
such as HIV and Ebola and emerging animal diseases — as we aspire
to be the premier research-intensive biopharmaceutical company in
the world.
In Canada, Merck markets a
broad range of vaccines, pharmaceutical and animal health products
and is one of the top R&D investors in Canada, with investments totaling $89 million in 2019 and more than $1.3 billion since 2000. Based in
Kirkland, Québec, Merck employs
approximately 650 people across the country. For more information
about our operations in Canada,
visit www.merck.ca and connect with us on YouTube and Twitter
@MerckCanada.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes
"forward-looking statements" within the meaning of the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995. These statements are based upon the current beliefs and
expectations of the company's management and are subject to
significant risks and uncertainties. If underlying assumptions
prove inaccurate or risks or uncertainties materialize, actual
results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States
and internationally; global trends toward health care cost
containment; technological advances, new products and patents
attained by competitors; challenges inherent in new product
development, including obtaining regulatory approval; the company's
ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of
international economies and sovereign risk; dependence on the
effectiveness of the company's patents and other protections for
innovative products; and the exposure to litigation, including
patent litigation and/or regulatory actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company's 2017
Annual Report on Form 10-K and the company's other filings with the
Securities and Exchange Commission (SEC) available at the SEC's
Internet site (www.sec.gov).
Please see the product monograph for BRENZYS®
(etanercept injection) at:
https://www.merck.ca/static/pdf/BRENZYS-PM_E.pdf
References
|
1 BRENZYS® Product Monograph. Merck
& Co. Inc. August 19, 2020.
|
2 Psoriasis. Canadian Dermatology
Foundation. 2020.
|
3 Psoriatic Arthritis. Arthritis
Society. 2020.
https://arthritis.ca/about-arthritis/arthritis-types-(a-z)/types/psoriatic-arthritis
|
4 BRENZYS® Product Monograph. Merck
& Co. Inc. August 19, 2020.
|
5 BRENZYS® Product Monograph. Merck
& Co. Inc. August 19, 2020.
|
6 BRENZYS® Product Monograph. Merck
& Co. Inc. August 19, 2020.
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7 BRENZYS® Product Monograph. Merck
& Co. Inc. August 19, 2020.
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8 Psoriasis. Canadian Dermatology
Foundation. 2020.
|
9 Psoriatic Arthritis. Arthritis
Society. 2020.
https://arthritis.ca/about-arthritis/arthritis-types-(a-z)/types/psoriatic-arthritis
|
10
BRENZYS® Product Monograph. Merck & Co. Inc. August 19,
2020.
|
11
Symptoms. Canadian Association of Psoriasis Patients. 2014.
canadianpsoriasis.ca/index.php/en/psoriasis/81-english/psoriasis/94-symptoms#:~:text=About%2080%25%20to%2090%25%20of,with%20silvery%20scales%20on%20top
|
12 BRENZYS® Product
Monograph. Merck & Co. Inc. August 19, 2020.
|
13 https://www.mayoclinic.org/diseases-conditions/juvenile-idiopathic-arthritis/symptoms-causes/syc-20374082
|
14 6
facts about Juvenile Idiopathic Arthritis. Montreal Children's
Hospital. 2020.
https://www.thechildren.com/health-info/conditions-and-illnesses/6-facts-about-juvenile-idiopathic-arthritis
|
15 BRENZYS® Product
Monograph. Merck & Co. Inc. August 19, 2020.
|
16 BRENZYS® Product
Monograph. Merck & Co. Inc. August 19, 2020.
|
17 Biosimilar Biologic Drugs in
Canada: Fact Sheet. Government of Canada. August 27,
2019.
|
18 Biosimilar Biologic Drugs in
Canada: Fact Sheet. Government of Canada. August 27,
2019.
|
19 BRENZYS® Product
Monograph. Merck & Co. Inc. August 19, 2020.
|
20 BRENZYS® Product
Monograph. Merck & Co. Inc. August 19, 2020.
|
21
BRENZYS® Product Monograph. Merck & Co. Inc. August 19,
2020.
|
22
BRENZYS® Product Monograph. Merck & Co. Inc. August 19,
2020.
|
SOURCE Merck