THOUSAND OAKS, Calif.,
Nov. 9, 2020 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced that data from its cardiovascular
(CV) portfolio will be presented at the American Heart Association
(AHA) Scientific Sessions 2020: A Virtual Experience, Nov. 13-17, 2020.
Amgen will present new analyses that provide further evidence of
the benefits of intensive lipid-lowering to reduce CV events with
Repatha® (evolocumab); new data
from the GOULD registry, a real-world study with more than 5,000
adults to better understand cholesterol treatment patterns in
patients with established cardiovascular disease (CVD); and new
first-in-human data for olpasiran (formerly AMG 890), a novel small
interfering RNA (siRNA) being developed for patients with CVD with
elevated lipoprotein(a) (Lp(a)), a risk factor for CV events.
Primary results from GALACTIC-HF, the Phase 3 outcomes trial of
omecamtiv mecarbil, an investigational cardiac myosin activator for
the treatment of heart failure with reduced ejection fraction
(HFrEF), will also be presented in a late-breaking clinical trial
session. Amgen announced in October that GALACTIC-HF met its
primary composite endpoint and did not meet its secondary endpoint
of reduction in CV death.
The new Repatha data contribute to Amgen's PROFICIO
(Program to Reduce LDL-C and Cardiovascular
Outcomes Following Inhibition of PCSK9
In Different POpulations) program of clinical and
real-world evidence studies investigating the impact of Repatha on
CVD and examining the use of lipid-lowering therapies across
multiple patient populations. To date, the PROFICIO program
consists of 50 clinical trials including more than 43,000 patients
worldwide with eight real-world evidence studies.
"We are committed to serving patients with cardiovascular
disease, and these data add further evidence to our PROFICIO
program, which supports more intensive and sustained lipid
management to achieve guideline recommended LDL-C levels," said
David M. Reese, M.D., executive vice
president of Research and Development at Amgen. "We also look
forward to sharing our first data for olpasiran, a novel siRNA,
designed to target lipoprotein(a), an independent, heritable risk
factor for heart attacks or other cardiovascular events."
Notable data being presented at the meeting include new analyses
from the FOURIER trial evaluating Repatha in reducing the risk of
major coronary events for atherosclerotic cardiovascular disease
(ASCVD) patients on statin therapy, with a history of percutaneous
coronary intervention, and a new meta-analysis across 48 randomized
clinical trials evaluating the efficacy of lipid-lowering
therapies, including Repatha, in reducing low-density lipoprotein
cholesterol (LDL-C) levels.
Results from GALACTIC-HF, one of the largest heart failure
trials ever conducted will be presented at a live, virtual,
embargoed AHA News Briefing on Thursday,
Nov. 12, 2020 from 1:30-2:30 p.m.
CT. Heart failure affects more than 64 million
worldwide,1 and despite advances in treatment and care
over the last decade, hospitalization and mortality rates remain
high.
A list of Amgen-sponsored abstracts at AHA Scientific Session
2020: A Virtual Experience can be found below and the full program
planner is available online:
GALACTIC-HF Primary Results
- Omecamtiv Mecarbil in Chronic Heart Failure with Reduced
Ejection Fraction: the Global Approach to Lowering Adverse Cardiac
Outcomes through Improving Contractility in Heart Failure
(GALACTIC-HF) Trial
Late Breaking Oral Presentation, Friday,
Nov. 13, 2020 10:35-10:45 a.m.
CT
The following virtual on-demand presentations will be available
online from Friday, Nov. 13,
2020 9:00 a.m. to Tuesday, Nov. 17, 2020 8:30 p.m. CT:
Heart Failure Data
- Characteristics and Outcomes of Patients With Heart Failure
With Reduced Ejection Fraction and a Worsening Heart Failure
Event (Abstract P427)
- Down-Titration of Renin-Angiotensin System Inhibitors After
Hospitalization for Heart Failure with Reduced Ejection
Fraction (Abstract P628)
- Enabling Advanced Real-World Evidence in Heart Failure: A
Pilot Study Defining Preferred Approaches to Electronic Health
Record Data Use (Abstract P970)
- Thirty Day Episode of Care Spending Following Heart Failure
Hospitalization Among Medicare Beneficiaries With Heart Failure
(Abstract P975)
Repatha Data
- A Contemporary Assessment of Lipid Lowering Therapies and
Low-Density Lipoprotein Cholesterol in Peripheral Artery
Disease (Abstract P54)
- A Novel Genetic Risk Score Predicts Ischemic Stroke in
Patients with Cardiometabolic Disease (Abstract 165)
- Cardiovascular Outcomes in Patients with Established
Atherosclerosis and LDLR Loss of Function: Results from the FOURIER
Trial (Abstract MP352)
- Effects Of Evolocumab In Patients With Prior Percutaneous
Coronary Intervention: An Analysis From The FOURIER Trial
(Abstract P2137)
- Efficacy of Lowering Low-Density Lipoprotein Cholesterol in
Elderly Subjects: A Systematic Review and Meta-Analysis of
Randomized Controlled Trials (Abstract P389)
- Evolocumab Inhibits the Acute Rise in Lipoprotein(a) in
Patients With Non-ST Elevation Myocardial Infarction (NSTEMI)-
Results From the EVACS Study (Abstract P392)
- Incorporation of High-Sensitivity Troponin along with the
AHA/ACC Cholesterol Guidelines for Improved Risk Stratification and
Targeted PCSK9 Inhibition in Atherosclerotic Cardiovascular
Disease (Abstract MP512)
- Reduction with Evolocumab in Complex Coronary Disease
Requiring Revascularization: Insights from the FOURIER Trial
(Abstract P394)
- Relative Efficacy of Alirocumab, Bempedoic Acid, Evolocumab,
Ezetimibe and Inclisiran Added to Statins for Reduction of
Low-Density Lipoprotein Cholesterol - A Network Meta-Analysis of
Randomized Clinical Trials (Abstract MP460)
- Relationship Between Baseline Low-Density Lipoprotein
Cholesterol and Percent Low-Density Lipoprotein Cholesterol
Reduction with Evolocumab in the FOURIER (Further Cardiovascular
Outcomes Research with PCSK9 Inhibition in Patients with Elevated
Risk) Trial (Abstract MP461)
Real-World Treatment Patterns
- Two-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) (Abstract P2255)
- Underuse of Combination Pharmacotherapy for Management of
Dyslipidemia versus Diabetes and Hypertension Among Patients with
Atherosclerotic Cardiovascular Disease (ASCVD): Insights from the
Getting to an Improved Understanding of Low-density Lipoprotein
Cholesterol and Dyslipidemia Management (GOULD) Registry
(Abstract MP459)
Olpasiran (AMG 890) Data
- Safety, Tolerability and Efficacy of Single-Dose AMG 890, a
Novel siRNA Targeting Lp(a), in Healthy Subjects and Subjects with
Elevated Lp(a) (Abstract P2338)
About the Repatha CV 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, was designed
to evaluate whether treatment with Repatha in combination with
statin therapy compared to placebo plus statin therapy reduces CV
events. The primary endpoint is the time to CV death, myocardial
infarction, stroke, hospitalization for unstable angina, or
coronary revascularization. The key secondary endpoint is the time
to CV 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 CV risk, including those managed by
statins, statin-intolerant patients, those with genetic disorders
and patients with atherosclerosis. To date,
the PROFICIO program consists of 50 trials including more
than 43,000 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.
GALACTIC-HF: Trial Design
GALACTIC-HF,2 (Global Approach to
Lowering Adverse Cardiac Outcomes
Through Improving Contractility in
Heart Failure), one of the largest Phase 3 global CV
outcomes studies in heart failure ever conducted, enrolled 8,256
patients in 35 countries with HFrEF, New York Heart Association
(NYHA) class II-IV, left ventricular ejection fraction (LVEF) ≤35%,
elevated natriuretic peptides and either current hospitalization
for heart failure or history of hospitalization or emergency
department visit for heart failure within a year. Patients were
randomized to either oral placebo or a starting dose of 25 mg
omecamtiv mecarbil twice daily (maintenance dose of 50 mg, 37.5 mg,
or 25 mg twice daily) guided by pharmacokinetic-guided dose
selection. A blood test, the QMS Omecamtiv Mecarbil Immunoassay
(the OM Test) was used to measure plasma levels of omecamtiv
mecarbil in each patient in order to guide selection of the
appropriate maintenance dose.
The primary composite endpoint of this double-blind,
placebo-controlled, event-driven trial was time to CV death or
first heart failure event (heart failure hospitalization and other
urgent treatment for heart failure). Secondary endpoints were: time
to CV death, patient reported outcomes (measured by Kansas City
Cardiomyopathy Questionnaire [KCCQ] Total Symptom Score [TSS]),
time to first heart failure hospitalization and time to all-cause
death.
About Omecamtiv Mecarbil and the Phase 3 Clinical Trials
Program
Omecamtiv mecarbil is an investigational selective cardiac
myosin activator, the first of a novel class of
myotropes3 designed to directly target the
contractile mechanisms of the heart, binding to and recruiting more
cardiac myosin heads to interact with actin during systole.
Preclinical research has shown that omecamtiv mecarbil increases
cardiac contractility without increasing intracellular myocyte
calcium concentrations or myocardial oxygen
consumption.4,5,6 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.
About Heart Failure
Heart failure is a grievous condition that affects more than 64
million people worldwide1 about half of whom have
reduced left ventricular function.7,8 It is the
leading cause of hospitalization and readmission in people age 65
and older.9,10 Despite broad use of standard
treatments and advances in care, the prognosis for patients with
heart failure is poor.11 An estimated one in five
people over the age of 40 are at risk of developing heart failure,
and approximately 50 percent of people diagnosed with heart failure
will die within five years of initial
hospitalization.12,13
About Olpasiran
Olpasiran (formerly known as AMG 890) is a small interfering RNA
(siRNA) that targets lipoprotein(a), also known as Lp(a). It is
being investigated for the treatment of ASCVD.
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.14 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 elevated lipids,
including high cholesterol and Lp(a), 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.15
Repatha is approved in more than 75 countries, including the
U.S., Japan, Canada, Australia, China 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.
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
collaborations, or potential collaborations, with any other
company, including BeiGene, Ltd. or any collaboration or potential
collaboration in pursuit of therapeutic antibodies against COVID-19
(including statements regarding such collaboration's, or our own,
ability to discover and develop fully-human neutralizing antibodies
targeting SARS-CoV-2 or antibodies against targets other than the
SARS-CoV-2 receptor binding domain, and/or to produce any such
antibodies to potentially prevent or treat COVID-19), 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 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, effects of pandemics or other widespread health problems
such as the ongoing COVID-19 pandemic on our business, outcomes,
progress, or effects relating to studies of Otezla as a potential
treatment for COVID-19, 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 its 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 Amgen projects. Discovery
or identification of new product candidates or development of new
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CONTACT: Amgen, Thousand Oaks
Trish Rowland, 805-447-5631
(media)
Jessica Akopyan, 447-447-0974
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