Combined Data From FOURIER and FOURIER-OLE
Studies Show Earlier, Longer Use of Repatha Reduces Total CV
Events
Analysis From Phase 2 OCEAN(a)-DOSE Study
Shows Olpasiran Markedly Reduced Lp(a) Concentration Irrespective
of Baseline Level
Amgen Convenes First LDL-C Action Summit to
Help Improve State of Cardiovascular Disease Care in the
U.S.
THOUSAND
OAKS, Calif., March 1,
2023 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today
announced new Repatha® (evolocumab) combined data from
the Phase 3 FOURIER and FOURIER Open Label Extension (OLE) studies
and the Phase 2 OCEAN(a)-DOSE study of investigational olpasiran,
an siRNA that reduces lipoprotein(a) [Lp(a)] by more than 90%.
Additional data from Amgen's Center for Observational Research and
Amgen funded investigator studies, including YELLOW-III from Mount
Sinai will be presented at the American College of Cardiology's
72nd Annual Scientific Session together with World Heart
Federation's World Congress of Cardiology (ACC.23/WCC) in
New Orleans, LA, March 4-6, 2023.
The Repatha data evaluated all primary endpoint events from the
patients enrolled in the parent FOURIER study (n=27,564), with a
median follow up of 2.2 years, and for patients who received
Repatha during FOURIER-OLE (n=6,635), for an additional 3 years of
follow up. These findings showed that over the duration of
follow-up, patients with atherosclerotic cardiovascular disease
(ASCVD) who were already receiving statin therapy had a reduction
in adverse cardiovasclar outcomes with earlier initiation of
Repatha. This was shown by the reduction in total cardiovascular
(CV) endpoint events (cardiovascular disease, myocardial
infarction, stroke, unstable angina or coronary revascularization)
in patients that had initiated Repatha in the parent study and
continued Repatha in the OLE, as compared to those who were in the
standard of care group in the parent study and only initiated
Repatha during the OLE.
"Amgen is at the forefront of lipid research and we are focused
on addressing some of the most significant cardiovascular disease
risk factors, including unmanaged LDL-C and Lp(a)," said
David M. Reese, M.D., executive vice
president of Research and Development at Amgen. "The robust body of
evidence on Repatha continues to underscore its clinical importance
as a transformative therapy in lowering LDL-C to reduce CV events
like heart attack and stroke in patients with ASCVD. We are proud
to provide Repatha to millions of patients worldwide at an
affordable cost."
Olpasiran is an investigational siRNA-based therapy that has
been shown to reduce Lp(a) by more than 90% in Phase 2. A new
analysis of the OCEAN(a) Dose study will examine whether the
percentage of Lp(a) reduction with olpasiran is affected by
baseline Lp(a) concentrations. The results showed that olpasiran
markedly reduced Lp(a) concentration irrespective of baseline level
in those with ASCVD and Lp(a) >150 nmol/L. These findings
provide important insights into how much Lp(a) reduction may be
achieved with olpasiran in settings where the Lp(a) burden is very
high.
While in New Orleans, Amgen
will also convene the first ever LDL-C Action Summit to address the
state of cardiovascular disease (CVD) care in the United States. This first meeting will
bring together key CVD community stakeholders, including the
American College of Cardiology, American Heart Association, Cardio
Health Alliance, Baim Institute for Clinical Research and PERFUSE,
Family Heart Foundation, National Forum and the National Lipid
Association, to understand the challenges in the treatment
landscape and discuss strategies and opportunities for
collaboratively improving lipid management among the highest risk
ASCVD patients.
"I look forward to presenting at this important summit convening
multiple stakeholders across academia, societies, and industry to
address the gaps in ASCVD care," said C. Michael Gibson, M.D., CEO of the non-profit Baim
Institute of Clinical Research, and Professor of Medicine,
Harvard. "Despite the clear benefits of
LDL lowering, people at risk are not being identified, and when
they are, they reach the guidelines goal only a third of the time.
The implementation science needs to be stepped up to match the
amazing basic/clinical science of lipid lowering. We need to work
together to get this changed."
For more information on the Amgen abstracts, see below. To learn
more about what Amgen is doing to address CVD, please
visit Amgen.com and follow us on Twitter, LinkedIn, Instagram,
TikTok and YouTube.
Amgen Abstracts
- Low-Density Lipoprotein Cholesterol Testing Following
Myocardial Infarction Hospitalization Among Medicare
Beneficiaries
Digital Presentation (#1135-005), Saturday,
March 4
- Characteristics of Proprotein Convertase Subtilisin/Kexin
Type 9 Inhibitor Monoclonal Antibody New Users and Changes in LDL-C
Using Real-World Data: A U.S. Perspective
Moderated Poster Session (#1008-05), Saturday, March 4, 10:00-10:10am CST
- Reduction in Total Cardiovascular Events with the PCSK9
Inhibitor Evolocumab in Patients with Cardiovascular Disease in the
Combined FOURIER and FOURIER Open-Label Extension (OLE)
Studies
Moderated Poster (#1003-13), Theater, Saturday, March 4, 11:00-11:10am CST
- Use of Negative Control Outcomes to Assess the Comparability
of PCSK9i mAb Treatment Protocols Following Myocardial
Infarction
Flatboard Poster (#1347-138), Saturday,
March 4, 1:45-2:30pm CST
- Association of Baseline Lipoprotein(a) and Percentage of
Lipoprotein(a) Lowering with Olpasiran
Moderated Poster (#1027-05), Saturday, March
4, 3:15-3:25pm CST
Investigator Sponsored Studies (ISS)
- Effect of Evolocumab on Coronary Plaque Characteristics in
Stable Coronary Artery Disease: A Multimodality Imaging Study
(YELLOW-III)
Late-Breaker (#403-14), Saturday Mar 4, 12:45 pm -
12:55 pm
- Pragmatic Implementation Science to Assess Lipid
Optimization in Peripheral Artery Disease: Primary Results of the
OPTIMIZE PAD-1 Trial
Flatboard Poster (#1726-007)
Monday Mar 6, 2023,10:45 am - 11:30 am
- Inhibition of PCSK9 with evolocumab modulates immune-cell
activation in high-risk ASCVD patients – The Metchnikoff Clinical
Trial
Moderated Poster (#1008-07), Saturday Mar 4,
2023, 10:15 am - 10:25 am
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 has been studied for
12 years in 50 clinical trials with over 51,000 patients.
Repatha is approved in more than 75 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.
About Olpasiran
Olpasiran (formerly known as AMG 890)
is a small interfering RNA (siRNA) that targets lipoprotein(a),
also known as Lp(a). We look forward to studying this treatment
further in Phase 3 clinical trial, which is currently
recruiting.
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 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 one
of the world's leading independent biotechnology
companies, has reached millions of patients around the world and is
developing a pipeline of medicines with breakaway
potential.
Amgen is one of the 30 companies that comprise the Dow
Jones Industrial Average and is also part of the Nasdaq-100 index.
In 2022, Amgen was named one of the "World's Best Employers" by
Forbes and one of "America's 100 Most Sustainable Companies" by
Barron's.
Repatha (evolocumab) Important U.S. Product
Information
INDICATIONS
Repatha® is indicated:
- In adults with established cardiovascular disease to reduce the
risk of myocardial infarction, stroke, and coronary
revascularization
- As an adjunct to diet, alone or in combination with other
low-density lipoprotein cholesterol (LDL-C)–lowering therapies, in
adults with primary hyperlipidemia, including heterozygous familial
hypercholesterolemia (HeFH), to reduce LDL–C
- As an adjunct to diet and other LDL-C-lowering therapies in
pediatric patients aged 10 years and older with HeFH, to reduce
LDL-C
- As an adjunct to other LDL–C-lowering therapies in adults and
pediatric patients aged 10 years and older with homozygous familial
hypercholesterolemia (HoFH), to reduce LDL–C
The safety and effectiveness of Repatha® have not been
established in pediatric patients with HeFH or
HoFH who are younger than 10 years old or in pediatric
patients with other types of hyperlipidemia.
IMPORTANT SAFETY INFORMATION
- Contraindication: Repatha® is contraindicated in
patients with a history of a serious hypersensitivity reaction to
evolocumab or any of the excipients in Repatha®. Serious
hypersensitivity reactions including angioedema have occurred in
patients treated with Repatha®.
- Hypersensitivity Reactions: Hypersensitivity
reactions, including angioedema, have been reported in patients
treated with Repatha®. If signs or symptoms of serious
hypersensitivity reactions occur, discontinue treatment with
Repatha®, treat according to the standard of care, and monitor
until signs and symptoms resolve.
- Adverse Reactions in Adults with Primary
Hyperlipidemia: The most common adverse reactions (>5%
of patients treated with Repatha® and 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. Hypersensitivity reactions occurred in 5.1% and 4.7% of
Repatha®-treated and placebo-treated patients, respectively. The
most common hypersensitivity 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%).
- Adverse Reactions in the Cardiovascular Outcomes
Trial: The most common adverse reactions (>5% of
patients treated with Repatha® and 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 treated with Repatha® compared with 7.7% in
patients that received placebo.
- Adverse Reactions in Pediatric Patients with
HeFH: The most common adverse reactions (>5% of
patients treated with Repatha® and more frequently than placebo)
were: nasopharyngitis, headache, oropharyngeal pain, influenza, and
upper respiratory tract infection.
- Adverse Reactions in Adults and Pediatric Patients with
HoFH: In a 12-week study in 49 patients, 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.
In an open-label extension study in 106 patients, including 14
pediatric patients, no new adverse reactions were observed.
- Immunogenicity: Repatha® is a human monoclonal
antibody. As with all therapeutic proteins, there is 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
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including any statements on the outcome, benefits and synergies of
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(including BeiGene, Ltd., Kyowa-Kirin Co., Ltd., or any
collaboration to manufacture therapeutic antibodies against
COVID-19), the performance of Otezla® (apremilast) (including
anticipated Otezla sales growth and the timing of non-GAAP EPS
accretion), the Five Prime Therapeutics, Inc. acquisition, the
Teneobio, Inc. acquisition, the ChemoCentryx, Inc. acquisition, or
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such as the ongoing COVID-19 pandemic on our business, and other
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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
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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
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from concept to product is uncertain; consequently, there can be no
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CONTACT: Amgen, Thousand Oaks
Megan Fox, 805-447-1423 (media)
Jessica Akopyan, 805-440-5721
(media)
Arvind Sood, 805-447-1060
(investors)
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