THOUSAND OAKS, Calif.,
Nov. 11, 2019 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that new data from its
cardiovascular portfolio will be presented at the American Heart
Association (AHA) Scientific Sessions 2019 in Philadelphia, Nov.
16-18. This includes new clinical and real-world studies
that provide further evidence of the benefits of intensive
lipid-lowering therapy with Repatha® (evolocumab) as
well as new data for omecamtiv mecarbil, a novel selective cardiac
myosin activator being developed for the treatment of heart failure
with reduced ejection fraction (HFrEF).
"The Amgen clinical and real-world data being presented at AHA
highlights our ongoing commitment to further the cardiovascular
community's understanding of Repatha's role in lowering high LDL-C,
one of the most important modifiable risk factors associated with
an increased risk of heart attack,"1 said David M. Reese, M.D., executive vice president
of Research and Development at Amgen. "In addition, we look forward
to presenting data that showcases the potential of omecamtiv
mecarbil for the treatment of heart failure. Despite advances in
care over the years, 50% of people diagnosed with heart failure
will die within five years of initial hospitalization so continued
advancements are needed in this area."2,3
Notable data from the Company's cardiovascular (CV) portfolio
include two new analyses from the Repatha cardiovascular outcomes
(FOURIER) study evaluating the efficacy and safety of
Repatha in patients with a recent heart attack, and the impact
of low-density lipoprotein cholesterol (LDL-C) lowering with
Repatha on cognitive function. In addition, a new post-hoc analysis
from the Phase 2 clinical trial, COSMIC-HF, evaluated the effects
of omecamtiv mecarbil on diastolic function.
Real-world Evidence Shows Need for More Intensive Treatment
in High-Risk Patients
Amgen is presenting the results of
nine real-world data analyses, including results from the GOULD
(Getting to an imprOved Understanding of Low-Density lipoprotein
cholesterol and dyslipidemia management) registry, a prospective
cohort of approximately 5,000 atherosclerotic cardiovascular
disease (ASCVD) patients with LDL-C above 70 mg/dL across 119 sites
in the U.S. These results demonstrate that a large proportion of
patients with a prior myocardial infarction (MI) do not receive
optimal secondary prevention therapy. Results from GOULD also
highlight gender differences in the use of high-intensity statins
as well as limited intensification of lipid lowering therapy over
one year of follow up in this ASCVD population with elevated
LDL-C.
A list of Amgen-sponsored abstracts at AHA 2019 can be found
online and below:
Omecamtiv Mecarbil clinical data
- The Effect of the Cardiac Myosin Activator, Omecamtiv
Mecarbil, on Diastolic Filling and Function in Chronic Systolic
Heart Failure (COSMIC-HF)
Monday,
Nov. 18, 2:45-2.50 p.m.
ET
Repatha clinical data
- Impact of Lowering LDL-C With Evolocumab on Everyday
Cognition in Participants From the FOURIER
Trial
Saturday, Nov. 16,
4:30-5 p.m. ET
- Effect of Evolocumab on Non-high-density Lipoprotein
Cholesterol and Apolipoprotein B Levels: An Analysis of
Double-blind and Open-label Extension Studies
Saturday, Nov. 16, 4:30-5
p.m. ET
- Use of a Genetic Risk Score to Predict Coronary and Vascular
Events and Benefit From Evolocumab Therapy in Patients With
Atherosclerotic Disease From the FOURIER Trial
Sunday, Nov. 17, 9:19-9:25
a.m. ET
- Evolocumab and Cardiovascular Outcomes in Patients With
Recent Myocardial Infarction: Analysis From
FOURIER
Monday, Nov. 18,
11:30 a.m.-12 p.m. ET
Real world treatment patterns
- Patient Perspectives on Cholesterol Lowering Therapies Among
Those Who Report Statin-associated Adverse Events. Results From a
National Survey in the Getting to an Improved Understanding of
Low-density Lipoprotein Cholesterol and Dyslipidemia Management
(GOULD) Registry
Sunday, Nov.
17, 3-3:30 p.m. ET
- Utilization of Cholesterol-lowering Therapies in Patients
With Chronic Kidney Disease and Atherosclerotic Cardiovascular
Disease (ASCVD). Results From a National Survey in the Getting to
an Improved Understanding of Low-density Lipoprotein Cholesterol
and Dyslipidemia Management (GOULD) Registry
Sunday, Nov. 17, 3-3:30
p.m. ET
- Does the Intensity of Lipid-Lowering Therapy Vary by Sex in
the United States? Insights From
Getting to an Improved Understanding of Low-Density Lipoprotein
Cholesterol and Dyslipidemia Management (GOULD): A Registry of High
Cardiovascular Risk Patients in the
United States
Sunday, Nov.
17, 3-3:30 p.m. ET
- Use of Guideline-Recommended Risk-Reduction Strategies Among
Patients With Prior MI: Insights From Getting to an Improved
Understanding of Low-Density Lipoprotein Cholesterol and
Dyslipidemia Management (GOULD)
Sunday, Nov. 17, 3-3:30
p.m. ET
- Is Lipid-Lowering Therapy Being Intensified in the United States?: Primary, One-year Results
of the Getting to an Improved Understanding of Low-density
Lipoprotein Cholesterol and Dyslipidemia Management (GOULD)
Registry of Patients With Atherosclerotic Cardiovascular Disease
(ASCVD)
Sunday, Nov. 17,
3-3:30 p.m. ET
- LDL-C Values and Lipid-Lowering Therapy Utilization Among
Medicare Beneficiaries With a Recent Myocardial
Infarction
Monday, Nov. 18,
1:30-2 p.m. ET
Identification of high-risk subpopulations
- Agreement Among Four Methods For Identifying Patients With
FH In A Large Healthcare System
Saturday, Nov. 16, 4:30-5
p.m. ET
Real-world LDL measurement and goal achievement
- Low-Density Lipoprotein-Cholesterol Lowering in Real-World
Patients Treated With Evolocumab
Sunday, Nov. 17, 3-3:30
p.m. ET
- Lipid testing trends in the U.S. before and after the
release of the 2013 ACC/AHA Cholesterol
Guidelines
Monday, Nov. 18,
1:30-2 p.m. ET
Burden of Cardiovascular Disease
Cardiovascular
disease (CVD) remains one of the most pressing public health issues
in the U.S., with someone in the country experiencing a heart
attack every 40 seconds.4 LDL-C, also known as bad
cholesterol, is one of the most important modifiable risk factors
for having a heart attack.5,6 About seven out of 10
adults in the U.S. with CVD have elevated LDL-C, despite optimal
lipid-lowering treatment.7 Additionally, 43% of patients
who have had a CV event, such as heart attack, will have at least
one new event within two years.8,9 Professional
guidelines around the world, including the American Heart
Association, the American College of Cardiology and the
European Society of Cardiology call for more intensive reduction of
LDL-C.10,11 The guidelines confirm the lower the LDL-C
value, the lower the risk of future CV events for patients with
CVD, and recommend intensive lipid-lowering treatment for very
high-risk patients.
About the Repatha Cardiovascular Outcomes (FOURIER)
Study
FOURIER (Further cardiovascular OUtcomes Research
with PCSK9 Inhibition in Subjects with Elevated Risk), a
multinational Phase 3 randomized, double-blind, placebo-controlled
trial, is designed to evaluate whether treatment with Repatha in
combination with statin therapy compared to placebo plus statin
therapy reduces cardiovascular events. The primary endpoint is the
time to cardiovascular death, myocardial infarction, stroke,
hospitalization for unstable angina, or coronary revascularization.
The key secondary endpoint is the time to cardiovascular death,
myocardial infarction or stroke.
Eligible patients with high cholesterol (LDL-C ≥70 mg/dL or
non-high-density lipoprotein cholesterol [non-HDL-C] ≥100 mg/dL)
and clinically evident ASCVD at more than 1,300 study
locations around the world were randomized to receive Repatha
subcutaneous 140 mg every two weeks or 420 mg monthly plus
effective statin dose; or placebo subcutaneous every two weeks or
monthly plus effective statin dose. Optimized statin therapy was
defined as at least atorvastatin 20 mg or equivalent daily with a
recommendation for at least atorvastatin 40 mg or equivalent daily
where approved. The study was event-driven and continued until at
least 1,630 patients experienced a key secondary endpoint.
FOURIER is part of Amgen's PROFICIO (Program to Reduce LDL-C and
cardiovascular Outcomes Following Inhibition of PCSK9 In
different pOpulations) program of clinical studies investigating
the impact of Repatha on LDL-C and CVD across multiple populations
at high cardiovascular risk, including those managed by statins,
statin-intolerant patients, those with genetic disorders and
patients with atherosclerosis. To date,
the PROFICIO program consists of 36 trials including more
than 38,000 patients worldwide.
GOULD Study Design
Getting to an
ImprOved Understanding of Low-Density Lipoprotein and
Dyslipidemia Management (GOULD) Registry is a multicenter,
observational registry of ASCVD patients, to describe LDL-C
treatment patterns in the U.S. and track them over time.
This registry and subsequent analysis sought to better understand
the adaptability of lipid management guidelines for patients with
ASCVD.
From December 2016 to April 2018, interactive
phone surveys with the lead physicians from each of the 120 U.S.
centers participating in the registry (1 physician from each
center) and patients (N=5,006) were conducted. Patients with ASCVD
receiving any pharmacological lipid-lowering therapy were eligible
for enrollment in 1 of 3 cohorts: 1) currently receiving a PCSK9i
antibody, 2) no PCSK9i and LDL-C 70-99 mg/dL, and 3) no PCSK9i and
LDL-C ≥ 100 mg/dL. Patients underwent a 1-year retrospective chart
review, followed by chart reviews and interviews every 6 months for
2 years.
About Omecamtiv Mecarbil and the Phase 3
Clinical Trials Program
Omecamtiv mecarbil is a
novel, selective cardiac myosin activator, also known as a cardiac
myotrope12, that binds to the catalytic domain of
myosin. Preclinical research has shown that cardiac myotropes
increase cardiac contractility without affecting intracellular
myocyte calcium concentrations or myocardial oxygen
consumption.13-15 Cardiac myosin is the
cytoskeletal motor protein in the cardiac muscle cell that is
directly responsible for converting chemical energy into the
mechanical force resulting in cardiac contraction.
Omecamtiv mecarbil is being developed for the
potential treatment of heart failure with reduced ejection fraction
(HFrEF) under a collaboration between Amgen and Cytokinetics, with
funding and strategic support from Servier. Omecamtiv
mecarbil is the subject of a comprehensive Phase 3 clinical
trials program comprised of GALACTIC-HF (Global Approach to
Lowering Adverse Cardiac Outcomes Through Improving Contractility
in Heart Failure), a large, Phase 3 global cardiovascular outcomes
study and METEORIC-HF (Multicenter Exercise Tolerance Evaluation of
Omecamtiv Mecarbil Related to Increased Contractility in Heart
Failure), a Phase 3 clinical trial designed to evaluate the effect
of treatment with omecamtiv mecarbil compared to placebo on
exercise capacity.
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.16
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 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.
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.17 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.
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
the acquisition of Otezla® (apremilast) , including
anticipated Otezla sales growth and the timing of non-GAAP EPS
accretion, as well as estimates of revenues, operating margins,
capital expenditures, cash, other financial metrics, expected
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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
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candidates that are derived from relationships may be subject to
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CONTACT: Amgen, Thousand
Oaks
Jessica Akopyan, 805-447-0974
(media)
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(investors)
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Accessed October 2019.
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