THOUSAND OAKS, Calif.,
Aug. 25, 2020 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced the presentation of 12 cardiovascular
scientific research abstracts, including clinical trial and
real-world evidence studies of
Repatha® (evolocumab), that add to the growing body
of evidence demonstrating the efficacy and safety of Repatha and
the importance of managing high-risk patients in accordance with
global treatment guidelines. The data will be presented at ESC
Congress 2020 – The Digital Experience, organized by
the European Society of Cardiology, Aug. 29–Sept. 1.
Notable abstracts include data from the first randomized
controlled Phase 3 study of a PCSK9 inhibitor, Repatha, in
pediatric patients with heterozygous familial hypercholesterolemia
(HeFH), which will be presented as a late-breaking abstract in an
oral presentation. HeFH is a genetic disorder that affects
approximately 1 in 250 individuals globally and results in high
levels of low-density lipoprotein cholesterol (LDL-C) at a very
young age despite treatment with statins and other
cholesterol-lowering therapies.1,2 With HeFH, there is
an accelerated development and increased lifetime risk of
atherosclerotic cardiovascular disease (ASCVD).3
A separate study across 18 European countries described how
lipid-lowering therapy (LLT) is used for primary and secondary
prevention of ASCVD and assessed how current practice impacts LDL-C
goals recommended by the ESC/EAS guidelines. A third study across
10 European countries evaluated the reduction of LDL-C by the
real-world use of Repatha in patients at very high-risk for a
cardiovascular event and simulated the associated 10-year
cardiovascular risk and risk reduction relative to baseline.
"The depth and breadth of data we are sharing with the
scientific community reflects our commitment to developing and
delivering transformative medicines that improve the lives of
patients, including pediatric patients with genetically high LDL-C,
who are at high lifetime risk for cardiovascular events," said
David M. Reese, M.D., executive vice
president of Research and Development at Amgen. "We are addressing
the ongoing unmet need in LDL-C by understanding how Repatha may
lower LDL-C in complex, high-risk populations who need more
intensive lipid lowering therapies as an optimal treatment to
achieve current clinical guidelines."
A list of Amgen-sponsored abstracts at ESC
Congress 2020 can be found online and include:
Repatha data
- HAUSER-RCT evolocumab in pediatric patients with
heterozygous familial hypercholesterolemia
Abstract 9097, Oral Presentation, Saturday,
Aug. 29, 11:20 a.m. CEST
- Achievement of ESC/EAS lipid treatment goals with evolocumab
in patients with type 2 diabetes: analyses of the BANTING and
BERSON trials
Abstract 8270, ePoster
- Does Evolocumab use in Europe match 2019 ESC/EAS lipid guidelines?
Results from the HEYMANS study
Abstract 8252, Oral Presentation, Sunday,
Aug. 30
- What potential risk reduction could be achieved with
evolocumab treatment? A simulation based on observational data from
a cohort of users in 10 European countries
Abstract 8928, ePoster
Cardiovascular disease state and treatment studies
- Differences in lipid treatment patterns in women versus men
in a large cohort of patients with atherosclerotic cardiovascular
disease in Ontario, Canada
Abstract 9758/9759, Oral Presentation, Tuesday, Sept. 1
- A longitudinal evaluation of cardiovascular risk factors,
treatment patterns, and outcomes in patients with documented
cardiovascular disease treated with lipid lowering therapy in the
United Kingdom
Abstract 8247, Abstract Only, Monday, Aug.
31
- Do European patients with peripheral arterial disease
receive optimal lipid lowering therapy and achieve LDL-C goals?
Results from the DA VINCI study
Abstract 8248, ePoster
- What is the potential cardiovascular risk reduction
associated with achieving LDL-C levels recommended in the ESC/EAS
guidelines for very high-risk patients? Data from 18 European
countries
Abstract 8929, ePoster
- Sex differences in the rates of incident and recurrent
coronary heart disease and all-cause mortality
Abstract 8884/9762, ePoster
- Low-density lipoprotein cholesterol goal attainment and
treatment patterns in a cohort of >143,000 patients with
atherosclerotic cardiovascular disease in Ontario, Canada
Abstract 8833/9745, ePoster
Cardiovascular disease cost burden on healthcare
- Resource utilization and costs associated with achieved
LDL-C levels in patients following a myocardial infarction treated
with lipid-lowering therapies in Spain
Abstract 82981, ePoster
- Disease burden of subsequent events among patients with
atherosclerotic cardiovascular disease in Taiwan
Abstract 82915/9792, ePoster
There will also be an "Invited Talk" at the ESC/EAS Joint
Session on DA VINCI Study: What have we learnt from 18 European
countries on lipid management? on Sunday, Aug. 30 at 10:40
a.m. CEST.
About Amgen in the Cardiovascular Therapeutic
Area
Building on more than three decades of experience in developing
biotechnology medicines for patients with serious
illnesses, Amgen is dedicated to addressing important
scientific questions to advance care and improve the lives of
patients with cardiovascular disease, the leading cause of
morbidity and mortality worldwide.4
Amgen's research into cardiovascular disease, and potential
treatment options, is part of a growing competency
at Amgen that utilizes human genetics to identify and
validate certain drug targets. Through its own research and
development efforts, as well as partnerships, Amgen is
building a robust cardiovascular portfolio consisting of several
approved and investigational molecules in an effort to address a
number of today's important unmet patient needs, such as high
cholesterol and heart failure.
About Amgen
Amgen is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its biologics manufacturing expertise to strive for
solutions that improve health outcomes and dramatically improve
people's lives. A biotechnology pioneer since
1980, Amgen has grown to be the world's largest
independent biotechnology company, has reached millions of patients
around the world and is developing a pipeline of medicines with
breakaway potential.
For more information, visit www.amgen.com and follow
us on www.twitter.com/amgen.
About Repatha® (evolocumab)
Repatha is a human monoclonal antibody that inhibits proprotein
convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9
and inhibits circulating PCSK9 from binding to the low-density
lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR
degradation and permitting LDLR to recycle back to the liver cell
surface. By inhibiting the binding of PCSK9 to LDLR, Repatha
increases the number of LDLRs available to clear LDL from the
blood, thereby lowering LDL-C levels.
Repatha is approved in more than 70 countries, including the
U.S., Japan, Canada and in all 28 countries that are
members of the European Union. Applications in other countries
are pending.
Important EU Product Information
In Europe, Repatha is approved for use in:
Hypercholesterolaemia and mixed dyslipidaemia
Repatha is indicated in adults with primary
hypercholesterolaemia (heterozygous familial and non–familial) or
mixed dyslipidaemia, as an adjunct to diet:
- in combination with a statin or statin with other
lipid-lowering therapies in patients unable to reach LDL–C goals
with the maximum tolerated dose of a statin or,
- alone or in combination with other lipid-lowering therapies in
patients who are statin-intolerant, or for whom a statin is
contraindicated.
Homozygous familial hypercholesterolaemia
Repatha is indicated in adults and adolescents aged 12 years and
over with homozygous familial hypercholesterolaemia in combination
with other lipid-lowering therapies.
Established atherosclerotic cardiovascular disease
Repatha is indicated in adults with established atherosclerotic
cardiovascular disease (myocardial infarction, stroke or peripheral
arterial disease) to reduce cardiovascular risk by lowering LDL-C
levels, as an adjunct to correction of other risk factors:
- in combination with the maximum tolerated dose of a statin with
or without other lipid-lowering therapies or,
- alone or in combination with other lipid-lowering therapies in
patients who are statin-intolerant, or for whom a statin is
contraindicated.
Posology
Primary hypercholesterolaemia and mixed dyslipidaemia in
adults
The recommended dose of Repatha is either 140 mg every two
weeks or 420 mg once monthly; both doses are clinically
equivalent.
Homozygous familial hypercholesterolaemia in adults and
adolescents aged 12 years and over
The initial recommended dose is 420 mg once monthly. After 12
weeks of treatment, dose frequency can be up–titrated to
420 mg once every 2 weeks if a clinically meaningful response
is not achieved. Patients on apheresis may initiate treatment with
420 mg every two weeks to correspond with their apheresis
schedule.
Established atherosclerotic cardiovascular disease in
adults
The recommended dose of Repatha is either 140 mg every two
weeks or 420 mg once monthly; both doses are clinically
equivalent.
Important Safety Information
This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
reactions.
Contraindications: Hypersensitivity to the active
substance or to any of the excipients.
Special Warnings and Precautions: Renal
impairment: There is limited experience with Repatha in
patients with severe renal impairment (defined as eGFR < 30
mL/min/1.73 m2). Repatha should be used with
caution in patients with severe renal impairment. Hepatic
impairment: In patients with moderate hepatic impairment, a
reduction in total evolocumab exposure was observed that may lead
to a reduced effect on LDL-C reduction. Therefore, close monitoring
may be warranted in these patients. Patients with severe hepatic
impairment (Child-Pugh C) have not been studied. Repatha should be
used with caution in patients with severe hepatic
impairment. Dry natural rubber: The needle cover of the
glass pre-filled syringe and of the pre-filled pen is made from dry
natural rubber (a derivative of latex), which may cause allergic
reactions. Sodium content: Repatha contains less than 1
mmol sodium (23 mg) per dose, i.e. it is essentially
'sodium-free'.
Interactions: No formal drug-drug interaction
studies have been conducted for Repatha. No studies on
pharmacokinetic and pharmacodynamics interaction between Repatha
and lipid-lowering drugs other than statins and ezetimibe have been
conducted.
Fertility, Pregnancy and Lactation: There are no or
limited amount of data from the use of Repatha in pregnant women.
Repatha should not be used during pregnancy unless the clinical
condition of the woman requires treatment with evolocumab. It is
unknown whether evolocumab is excreted in human milk. A risk to
breastfed newborns/infants cannot be excluded. No data on the
effect of evolocumab on human fertility are
available.
Undesirable Effects: The following common
(> 1/100 to < 1/10) adverse reactions have been reported
in pivotal, controlled clinical studies: influenza,
nasopharyngitis, upper respiratory tract infection, rash, nausea,
back pain, arthralgia, injection site reactions. Please consult
the SmPC for a full description of undesirable
effects.
Pharmaceutical Precautions: Store in a refrigerator
(2 degrees C – 8 degrees C). Do not freeze. Keep the
pre-filled syringe or the pre-filled pen in the original carton in
order to protect from light. If removed from the refrigerator,
Repatha may be stored at room temperature (up to 25 degrees C) in
the original carton and must be used within 1 month.
Important U.S. Product Information
Repatha is a PCSK9 (proprotein convertase subtilisin/kexin type
9) inhibitor antibody indicated:
- to reduce the risk of myocardial infarction, stroke, and
coronary revascularization in adults with established
cardiovascular disease.
- as an adjunct to diet, alone or in combination with other
lipid-lowering therapies (e.g., statins, ezetimibe), for treatment
of adults with primary hyperlipidemia (including heterozygous
familial hypercholesterolemia [HeFH]) to reduce low-density
lipoprotein cholesterol (LDL-C).
- as an adjunct to diet and other LDL-lowering therapies (e.g.,
statins, ezetimibe, LDL apheresis) in patients with homozygous
familial hypercholesterolemia (HoFH) who require additional
lowering of LDL-C.
The safety and effectiveness of Repatha have not been
established in pediatric patients with HoFH who are younger than 13
years old or in pediatric patients with primary hyperlipidemia or
HeFH.
Important U.S. Safety Information
Contraindication: Repatha is contraindicated in
patients with a history of a serious hypersensitivity reaction to
Repatha. Serious hypersensitivity reactions including angioedema
have occurred in patients treated with Repatha.
Allergic reactions: Hypersensitivity reactions (e.g.
angioedema, rash, urticaria) have been reported in patients treated
with Repatha, including some that led to discontinuation of
therapy. If signs or symptoms of serious allergic reactions occur,
discontinue treatment with Repatha, treat according to the standard
of care, and monitor until signs and symptoms resolve.
Adverse reactions: The most common adverse reactions
(>5% of patients treated with Repatha and occurring more
frequently than placebo) were: nasopharyngitis, upper respiratory
tract infection, influenza, back pain, and injection site
reactions.
From a pool of the 52-week trial and seven 12-week trials: Local
injection site reactions occurred in 3.2% and 3.0% of
Repatha-treated and placebo-treated patients, respectively. The
most common injection site reactions were erythema, pain, and
bruising.
Allergic reactions occurred in 5.1% and 4.7% of Repatha-treated
and placebo-treated patients, respectively. The most common
allergic reactions were rash (1.0% versus 0.5% for Repatha and
placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4%
versus 0.2%), and urticaria (0.4% versus 0.1%).
The most common adverse reactions in the Cardiovascular Outcomes
Trial (>5% of patients treated with Repatha and occurring more
frequently than placebo) were: diabetes mellitus (8.8% Repatha,
8.2% placebo), nasopharyngitis (7.8% Repatha, 7.4% placebo), and
upper respiratory tract infection (5.1% Repatha, 4.8%
placebo).
Among the 16,676 patients without diabetes mellitus at baseline,
the incidence of new-onset diabetes mellitus during the trial was
8.1% in patients assigned to Repatha compared with 7.7% in those
assigned to placebo.
Homozygous Familial Hypercholesterolemia (HoFH): The
adverse reactions that occurred in at least two patients treated
with Repatha and more frequently than placebo were: upper
respiratory tract infection, influenza, gastroenteritis, and
nasopharyngitis.
Immunogenicity: Repatha is a human monoclonal
antibody. As with all therapeutic proteins, there is a potential
for immunogenicity with Repatha.
Please contact Amgen Medinfo at 800-77-AMGEN (800-772-6436)
or 844-REPATHA (844-737-2842) regarding
Repatha® availability or find more information,
including full Prescribing Information,
at www.amgen.com and www.Repatha.com.
Forward-Looking Statements
This news release contains forward-looking statements that are
based on the current expectations and beliefs of Amgen. All
statements, other than statements of historical fact, are
statements that could be deemed forward-looking statements,
including any statements on the outcome, benefits and synergies of
collaborations, or potential collaborations, with any other
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regarding such collaboration's, or our own, ability to discover and
develop fully-human neutralizing antibodies targeting SARS-CoV-2 to
potentially prevent or treat COVID-19), BeiGene, Ltd., or the
Otezla® (apremilast) acquisition, including anticipated
Otezla sales growth and the timing of non-GAAP EPS accretion, as
well as estimates of revenues, operating margins, capital
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reimbursement activities and outcomes, effects of pandemics or
other widespread health problems such as the ongoing COVID-19
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to studies of Otezla as a potential treatment for COVID-19, and
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CONTACT: Amgen, Thousand Oaks
Trish Rowland, 805-447-5631
(Media)
Jessica Akopyan, 805-447-0974
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Arvind Sood, 805-447-1060
(Investors)
References
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1 The FH
Foundation. Heterozygous vs Homozygous FH.
https://thefhfoundation.org/heterozygous-vs-homozygous-fh. Accessed
August 2020.
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2 National Human Genome Research
Institute. Learning About Familial Hypercholesterolemia.
http://www.genome.gov/25520184. Accessed July 2020.
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3 McGowan
MP, et al. J Am Heart Assoc. 2019;8:e013225.
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4 World Health Organization.
Cardiovascular diseases (CVDs) fact sheet.
http://www.who.int/mediacentre/factsheets/fs317/en/.
Accessed July 2020.
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