New Repatha® (evolocumab) Data Show
No Decline in Cognitive Function Associated With Very Low Levels of
LDL-C
Olpasiran Research Provides Further Insights
Into Cardiovascular Risks Associated With Elevated Lp(a)
Amgen Provides Updates on Efforts to Advance
Bold Ambition of Halving the Number of Heart Attacks and Strokes by
2030
THOUSAND
OAKS, Calif., Nov. 10,
2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
announced new data reinforcing the safety and efficacy of
Repatha® (evolocumab) from the FOURIER Open Label
Extension (OLE) [FOURIER-OLE] trial at the American Heart
Association (AHA) Scientific Sessions 2023 in Philadelphia. These presentations will focus
on the reduction of a known cardiovascular disease (CVD) risk
factor, LDL "bad" cholesterol (LDL-C). Amgen will also present new
research from the Phase 2 OCEAN(a)-DOSE study of its
investigational small interfering RNA (siRNA) olpasiran that
will focus on a primarily genetically determined and presumed
independent CVD risk factor, lipoprotein(a)
[Lp(a)].1,2,3,4,5
Repatha Data Reinforces Benefits of Low LDL-C
Data from the EBBINGHAUS sub-study of the FOURIER-OLE is the
first to evaluate the impact of long-term lowering of LDL-C on
cognitive function following administration of Repatha in adult
patients with atherosclerotic cardiovascular disease (ASCVD). The
data showed patients treated with Repatha did not
experience any apparent cognitive decline following a median
achieved LDL-C of 34 mg/dL through a median follow-up period of 5.1
years.
"Cardiovascular disease is a leading public health crisis in
the United States. Amgen remains
steadfast in our commitment to reduce the risk of heart attack and
stroke, starting with lowering levels of LDL-C, one of the most
modifiable risk factors," said Paul
Burton, senior vice president and chief medical officer at
Amgen. "Repatha continues to be an effective option in helping
people with cardiovascular disease manage their LDL-C, and this
FOURIER-OLE data further demonstrates that long-term lowering of
LDL-C levels come with no decline in cognitive function."
An additional analysis combining FOURIER and FOURIER-OLE data
for 152 OLE participants originally randomized to receive Repatha
showed that long-term treatment with this medication had no
significant impact on measures of executive function, working and
episodic memory, and psychomotor speed over time as compared to
baseline. No new safety signals were identified in the
analyses.
"The neurocognitive data highlighting long-term use of
evolocumab is highly encouraging for the cardiovascular community,"
said Robert Giugliano, M.D., S.M.,
Senior Investigator, TIMI Study Group, Staff Physician,
Cardiovascular Medicine, Brigham and Women's Hospital, Professor of
Medicine, Harvard Medical School, and
FOURIER-OLE investigator. "In addition to reiterating the
neurocognitive safety of evolocumab, this study provides reassuring
information for patients and clinicians that sustained very low
levels of LDL-C over the long-term does not increase cognitive
impairment."
Olpasiran Research on Risks Associated with Elevated
Lp(a)
Amgen also shared new research from the OCEAN(a)-DOSE study on
Lp(a) involving its investigational olpasiran. Evidence suggests
that elevated Lp(a) contributes to cardiovascular events, including
heart attack, stroke and peripheral arterial disease.3,4
Data will be presented on the intraindividual variability in serial
Lp(a) concentration among placebo-treated patients in the
OCEAN(a)-DOSE trial. Additional research presented at AHA will
include Mass General Brigham Lp(a)
registry data on whether the association between Lp(a) and major
adverse cardiovascular events (MACE) differs based on baseline
ASCVD status. This research investigates the threshold for defining
Lp(a) in patients both with and without ASCVD.
LDL-C Action Summit & LDL Awareness to Action
Implementation Consortium
Amgen will reconvene the LDL-C Action Summit and the newly
formed LDL Awareness to Action Implementation Consortium ahead of
AHA. The LDL-C Action Summit brings together key CVD community
stakeholders to discuss strategies and opportunities for
collaboratively improving lipid management, while the Consortium
convenes leading cardiovascular healthcare systems and research
institutions to focus on improving LDL-C testing and accelerating
the implementation of evidence-based approaches into clinical
practice. Both initiatives are part of Amgen's commitment to
advancing its bold ambition of halving the number of heart attacks
and strokes by 2030.
For more information on the Amgen abstracts, see below.
Abstracts and Presentation Times:
Amgen Sponsored Abstracts
Repatha® (evolocumab)
- Long-Term Efficacy of Evolocumab in Patients With and
Without Multivessel Coronary Artery Disease (FOURIER
OLE)
Abstract #Sa3071, Poster Session, Zone 3, Science and
Technology Hall, Level 2, Saturday, Nov.
11 from 3-4:15 p.m. EST
- Association Between Achieved LDL-C Levels and Long-Term
Cardiovascular and Safety Outcomes: An Analysis
of FOURIER-OLE
Invited Encore Oral Presentation, Room
121B, Sunday,
Nov. 12 from 3:30-3:35 p.m. EST (previously published
in Circulation, Feb.
2023)
- Low Rates of Achievement of LDL-C<55dL Among
Patients with ASCVD in the United
States: Findings from the cvMOBIUS Registry
Abstract
#Su3278, Poster Session, Zone 3, Science and Technology Hall, Level
2, Hall A-D, Sunday, Nov. 12 from 3-4:15 p.m. EST
- Racial/Ethnic Disparities in Low-Density Lipoprotein
Cholesterol Testing Following Myocardial Infarction Hospitalization
Among Medicare Beneficiaries in the
United States, by State
Abstract #Su3242, Poster Session, Zone 3, Science and
Technology Hall, Level 2, Sunday, Nov. 12 from 11:30
a.m.-12:45 p.m. EST
- Long-Term Neurocognitive Safety of LDL-C Lowering With
Evolocumab: Open-Label Extension Data From FOURIER
Abstract
#304, Oral Presentation, Room 204C, Monday, Nov. 13 from
10:30-10:40 a.m. EST
- Persistence and Adherence to Proprotein Convertase
Subtilisin/kexin type 9 Monoclonal Antibodies and Ezetimibe in
Real-World Settings
Abstract #Mo3065, Poster Session, Zone
3, Science and Technology Hall, Level 2, Monday, Nov. 13 from
10:30-11:45 a.m. EST
- 104-Week Safety and Effectiveness of Low-Density Lipoprotein
Cholesterol-Lowering Therapy with Evolocumab in Patients with
Familial Hypercholesterolemia/ Hypercholesterolemia in Japan: Results of Post-Marketing
Surveillance
Abstract #Mo3012, Poster Session, Zone 3,
Science and Technology Hall, Level 2, Monday, Nov. 13 from
10:30-11:45 a.m. EST
Olpasiran
- Intraindividual Variability in Serial Lipoprotein(a)
Concentration Among Placebo-Treated Patients in the OCEAN(a)-DOSE
Trial
Abstract #Sa1005, Poster Session, Zone 1, Science and
Technology Hall, Level 2, Saturday, Nov. 11 from 11:30 a.m.-12:45
p.m. EST
- The Association of Lipoprotein(a) with Major Adverse
Cardiovascular Events Among Individuals With and Without Baseline
Atherosclerotic Cardiovascular Disease: The Mass
General Brigham Lp(a) Registry
Abstract #MDP278,
Moderated Digital Poster 4, Science and Technology Hall, Level 2,
Monday, Nov. 13 from 12:10-12:15 p.m. EST
Investigator-Sponsored Studies (ISS)
- Stem Cell Factor Associated with Critical Limb Ischemia
in Patients with Peripheral Artery Disease
Abstract #Su3229,
Poster Session, Zone 3, Science and Technology Hall, Level 2,
Sunday, Nov. 12 from 3:30-4:45 p.m. EST
- CAD Polygenic Risk Score and Incident Complex Coronary
Revascularization in Adults with Atherosclerosis
Abstract
#565, Poster Session, Zone 2, Science and Technology Hall, Level 2,
Monday, Nov. 13, 2023 from 9:50-9:55 a.m. EST
Amgen's Cardiovascular Ambition
Cardiovascular disease
is a leading public health crisis in the
United States, with a heart attack or stroke occurring every
40 seconds. High levels of LDL ("bad") cholesterol are a main
culprit for cardiovascular events. Amgen is committed to advancing
a bold ambition: to halve the number of heart attacks and strokes
by 2030. To change the cardiovascular disease treatment landscape,
Amgen is working together alongside community stakeholders,
healthcare systems and research institutions to drive urgency and
action around the importance of LDL-C testing.
For more information about LDL and to learn how to get a free
LDL-C test*, visit WhatIsMyLDL.com.
*Terms and conditions apply. Programs subject to change;
quantities may be limited.
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 the Phase 3 clinical trial OCEAN(a)-Outcomes, which is
currently recruiting.
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.
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 2023, Amgen was named one of "America's Greatest
Workplaces" by Newsweek, one of "America's Climate Leaders"
by USA Today and one of the "World's Best Companies" by
TIME.
For more information, visit Amgen.com and follow us
on X (formerly known as Twitter),
LinkedIn, Instagram, TikTok, YouTube and Threads.
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including any statements on the outcome, benefits and synergies of
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CONTACT: Amgen, Thousand Oaks
Madison Howard, 773-636-4910
(media)
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References:
- Wilson DP, et al. Clin Lipidol. 2019;13(3):374-92.
- Reyes-Soffer G, et al. Arterioscler Thromb Vasc Biol.
2022;42(1):e48-e60.
- Kronenberg F, et al. Eur Heart
J. 2022;43(39):3925-3946.
- Tsimikas S, Stroes ESG. Atherosclerosis. 2020;300:1-9.
- Tsimikas S, et al. J Am Coll Cardiol. 2018;71(2):177-192.
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