THOUSAND OAKS, Calif.,
Aug. 28, 2019 /PRNewswire/
-- Amgen (NASDAQ: AMGN) today announced the presentation of 14
cardiovascular scientific research abstracts, including studies
evaluating the safety and efficacy of Repatha®
(evolocumab) by race and ethnicity and further examining its
clinical benefit in patients with familial hypercholesterolemia
(FH).1,2 The data will be presented at ESC Congress
2019, organized by the European Society of Cardiology, in
Paris, Aug. 31–Sept. 4.
Further independent data, generated in Europe, will be presented for Repatha from the
EVOlocumab for early reduction of LDL-cholesterol levels in
Patients with Acute Coronary Syndromes (EVOPACS)
study.3
"Cardiovascular disease is one of the greatest health challenges
we face today, impacting more than 49 million people in the EU
alone.4 While it is critical to reduce low-density
lipoprotein cholesterol (LDL-C) levels in patients who have had
multiple cardiovascular events or a recent heart attack, we
continue to see elevated LDL-C in high-risk patients, despite
treatment with statins and other traditional lipid-lowering
therapies," said David M. Reese, M.D., executive vice
president of Research and Development at Amgen. "Amgen is committed
to building a body of evidence to support the clinical profile of
Repatha and demonstrate its high value in patients at elevated risk
of suffering another event."
Lowering LDL-C, or "bad" cholesterol, is a key modifiable risk
factor in reducing the risk of cardiovascular events such as heart
attack and stroke.5 Alongside ESC Congress 2019, Amgen
is hosting #ProtectUrLife, an innovative, European-city-based heart
screening and education program at the ESC Congress public event in
Paris. Members of the public will
be offered a free non-invasive screening that measures cholesterol
levels, one of the most important risk factors associated with an
increased risk of heart attack.
"Our #ProtectUrLife screening and education program aims to
improve the prevention, evaluation and care of serious medical
conditions, including cardiovascular disease, that continue to be
underdiagnosed and undermanaged. Moving on from the traditional
'break and fix' approach, the program uses a 'predict and prevent'
model, providing education on risk reduction and empowering the
public to act on knowledge to help prevent life-altering events
such as heart attacks and stroke," said Isma Benattia, M.D., vice president of Medical
for the European Region at Amgen.
The two-day #ProtectUrLife event will be held at the Public
Event Village in front of the Hôtel de Ville in Paris from 11 a.m. to 7
p.m. CEST during the weekend of Aug. 31–Sept. 1, 2019. The
Public Event Village is organized by the ESC, the City of Paris and the French Society of
Cardiology, and around 10,000 visitors are expected to attend each
day.
A list of Amgen-sponsored abstracts at ESC Congress 2019 can be
found online and below:
Repatha® (evolocumab) data
- Effectiveness of evolocumab for patients with familial
hypercholesterolemia (FH) in European clinical
practice
Lipids, Saturday, Aug.
31, 12:35-1:25 p.m. CET
- Clinical profile of patients initiating evolocumab in
Spanish Cardiology Units: A RETrospective, Observational Study of
Real-World Clinical Practice (RETOSS-Cardio)
Hypertension
risk factors and lifestyle, Sunday, Sept.
1, 10:05-10:55 a.m. CET
- Cost-effectiveness of evolocumab in patients with high
atherosclerotic cardiovascular risk in Sweden
How good/bad are we in treating
lipids, Sunday, Sept. 1, 10:05-10:55 a.m. CET
- Effect of evolocumab on lipoprotein(a) levels: results
across 15 studies
Lipids, Tuesday, Sept. 3,
10:05-10:55 a.m. CET
- Effects of evolocumab on LDL-C by race and ethnicity: an
analysis of double-blind and open-label extension studies
Lipids, Tuesday, Sept. 3,
3:50-4:40 p.m. CET
Cardiovascular disease treatment studies
- Lower use of statins among patients with peripheral artery
disease compared with those with coronary heart
disease
Lipids, Saturday, Aug.
31, 12:35-1:25 p.m. CET
- Association of adherence and treatment intensity of
lipid-lowering therapy with cardiovascular outcomes and all-cause
mortality in very high-risk patients in Germany
Lipids, Saturday, Aug. 31, 12:35-1:25 p.m. CET
- Screening and treatment of familial hypercholesterolemia
(FH) in a French sample of ambulatory care: a retrospective
longitudinal study
Lipids, Saturday,
Aug. 31, 12:35-1:25 p.m.
CET
- Patient characteristics and treatment patterns in patients
on lipid-lowering therapies following an acute coronary syndrome in
France
Lipids, Saturday, Aug. 31, 12:35-1:25 p.m. CET
- Oxidized phospholipids on apolipoprotein B-100 among black
U.S. adults with and without PCSK9 loss-of-function
variants
Lipids, Tuesday, Sept.
3, 10:05-10:55 a.m. CET
Cardiovascular disease state
- Electronic health records (EHRs) data validation in
atherosclerotic/cardiovascular clinical phenotypes
Digital
health, Saturday, Aug. 31,
12:35-1:25 p.m. CET
- Contrasting the risk for atherosclerotic cardiovascular
disease events among individuals with lower extremity peripheral
artery disease, coronary heart disease and cerebrovascular
disease
Clinical epidemiology and prevention, Monday, Sept. 2, 10:05-10:55 a.m. CET
- Recurrent coronary heart disease in the year following
myocardial infarction among U.S. men and women between 2008 and
2015
Coronary Artery Disease – Epidemiology, Prognosis,
Outcome, Tuesday, Sept. 3,
11 a.m. CET
- Death, debility, and destitution following recurrent
myocardial infarction in older adults
Risk Factors and
Prevention, Tuesday, Sept. 3,
3:50-4:40 p.m. CET
Investigator sponsored studies
- EVOlocumab for early reduction of LDL-cholesterol levels in
Patients with Acute Coronary Syndromes (EVOPACS) – A randomized,
double-blind, placebo-controlled multicenter study
(ISS)
Acute Coronary Syndromes, Late-Breaking Science,
Saturday, Aug. 31, 09:17 a.m. CET
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.7
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 #ProtectUrLife
The #ProtectUrLife campaign aims
to improve heart and bone health through prevention, evaluation and
care of cardiovascular disease and osteoporosis. Using the 'predict
and prevent' model, #ProtectUrLife events offer free screening and
individualized risk assessments for members of the public to help
predict who is at risk for heart attacks, stroke and bone
fractures. Education for improving heart and bone health is
offered, empowering the public to act on knowledge to help prevent
life-altering events. The #ProtectUrLife initiative is also
designed to empower cities and policy-makers to develop sustainable
healthcare systems that benefit their residents.
Launched in 2018, the campaign is led by Amgen and has been
developed in partnership with EIT Health, the International
Osteoporosis Foundation, the World Heart Federation, the Technical
University of Munich, the
University of Barcelona and BePatient.
The campaign unites a European consortium composed of experts,
start-ups, professional societies, patient associations, healthcare
professionals, hospitals and cities.
For more information about the campaign visit
www.protecturlife.eu and follow us on
www.twitter.com/protecturlife and
www.facebook.com/ProtectUrLife19/
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)6
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 60 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 estimates of revenues,
operating margins, capital expenditures, cash, other financial
metrics, expected legal, arbitration, political, regulatory or
clinical results or practices, customer and prescriber patterns or
practices, reimbursement activities and outcomes and other such
estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
below and more fully described in the Securities and Exchange
Commission reports filed by Amgen, including our most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and current reports on Form 8-K. Unless otherwise noted,
Amgen is providing this information as of the date of this news
release and does not undertake any obligation to update any
forward-looking statements contained in this document as a result
of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project.
Discovery or identification of new product candidates or
development of new indications for existing products cannot be
guaranteed and movement from concept to product is uncertain;
consequently, there can be no guarantee that any particular product
candidate or development of a new indication for an existing
product will be successful and become a commercial product.
Further, preclinical results do not guarantee safe and effective
performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes, even adequately
modeled by computer or cell culture systems or animal models. The
length of time that it takes for us to complete clinical trials and
obtain regulatory approval for product marketing has in the past
varied and we expect similar variability in the future. Even when
clinical trials are successful, regulatory authorities may question
the sufficiency for approval of the trial endpoints we have
selected. We develop product candidates internally and through
licensing collaborations, partnerships and joint ventures. Product
candidates that are derived from relationships may be subject to
disputes between the parties or may prove to be not as effective or
as safe as we may have believed at the time of entering into such
relationship. Also, we or others could identify safety, side
effects or manufacturing problems with our products, including our
devices, after they are on the market.
Our results may be affected by our ability to successfully
market both new and existing products domestically and
internationally, clinical and regulatory developments involving
current and future products, sales growth of recently launched
products, competition from other products including biosimilars,
difficulties or delays in manufacturing our products and global
economic conditions. In addition, sales of our products are
affected by pricing pressure, political and public scrutiny and
reimbursement policies imposed by third-party payers, including
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may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
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prevail in present and future intellectual property litigation. We
perform a substantial amount of our commercial manufacturing
activities at a few key facilities, including in Puerto Rico, and also depend on third parties
for a portion of our manufacturing activities, and limits on supply
may constrain sales of certain of our current products and product
candidate development. We rely on collaborations with third parties
for the development of some of our product candidates and for the
commercialization and sales of some of our commercial products. In
addition, we compete with other companies with respect to many of
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of new products. Further, some raw materials, medical devices and
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discovery of significant problems with a product similar to one of
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ability of our Board of Directors to declare a dividend or our
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are favorable to us, or at all.
The scientific information discussed in this news release
relating to new indications for our products is preliminary and
investigative and is not part of the labeling approved by the U.S.
Food and Drug Administration for the products. The products are not
approved for the investigational use(s) discussed in this news
release, and no conclusions can or should be drawn regarding the
safety or effectiveness of the products for these uses.
CONTACT: Amgen, Thousand
Oaks
Trish Hawkins, 805-447-5631
(Media)
Jessica Akopyan, 805-447-0974
(Media)
Arvind Sood, 805-447-1060
(Investors)
References
1 Effects of evolocumab on LDL-C by race and
ethnicity: an analysis of double-blind and open-label extension
studies. Presented at ESC 2019, Lipids, Tuesday 3 September,
15:50-16:40 CET.
2 Effectiveness of evolocumab for patients with
familial hypercholesterolaemia (FH) in European clinical practice.
Presented at ESC 2019, Lipids, Saturday 31 August, 12:35-13:25 CET.
3 EVOlocumab for early reduction of LDL-cholesterol
levels in Patients with Acute Coronary Syndromes (EVOPACS) – A
randomized, double-blind, placebo-controlled multicenter study
(ISS) Acute Coronary Syndromes, Late-Breaking Science, Saturday, Aug. 31, 09:17
CET.
4 Wilkins E, Wilson L, Wickramasinghe K, Bhatnagar
P, Leal J, Luengo-Fernandez R, Burns R, Rayner M, Townsend N
(2017). European Cardiovascular Disease Statistics 2017. European
Heart Network, Brussels.
5 American Heart Association (2017): What your
cholesterol levels mean
https://www.heart.org/en/health-topics/cholesterol/about-cholesterol/what-your-cholesterol-levels-mean Accessed
July 2019
6 Repatha Prescribing Information; Amgen,
Thousand Oaks, CA, 2018.
7 World Health Organization. Cardiovascular diseases
(CVDs) fact sheet.
http://www.who.int/mediacentre/factsheets/fs317/en/. Accessed
July 2019
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