THOUSAND OAKS, Calif.,
Nov. 16, 2019 /PRNewswire/ -- Amgen
today announced a new analysis from the Repatha®
(evolocumab) cardiovascular outcomes (FOURIER) study that evaluates
the effectiveness of Repatha in patients who have suffered a
recent myocardial infarction (MI). The analysis showed that
patients who experienced a recent MI (less than one year) were at
higher risk of subsequent cardiovascular (CV) events compared to
patients who had an MI over a year ago. In the analysis, the risk
reduction for experiencing a heart attack, stroke or CV death, in
Repatha-treated patients treated within one year post MI was
25% compared to 15% in those patients with a more distant MI. The
results will be presented at the American Heart Association Annual
Scientific Sessions in Philadelphia on Monday,
Nov. 18.
"Nearly 1 in 5 patients will have a recurrent CV event during
the first year after a heart attack which makes that year a
critical time for high-risk patients1," said
Robert Giugliano, M.D., FOURIER
executive committee member and a senior investigator at
the TIMI Study
Group at Brigham and Women's
Hospital and Professor of Medicine at Harvard Medical School. "These results demonstrate
the importance of intensive lipid-lowering therapy in the first
year following a heart attack and provide additional evidence that
evolocumab significantly reduces CV risk and improves outcomes for
high-risk patients."
In this analysis of the landmark FOURIER outcomes study, 5,711
patients who experienced an MI within one to 12 months of
randomization were compared to 16,609 patients with a more distant
event (>12 months prior to randomization) to assess the efficacy
of Repatha on the primary endpoint (CV death, MI, stroke, unstable
angina or coronary revascularization) and the key secondary
endpoint (CV death, MI or stroke).
"Far too many patients remain at risk of another CV event
because they are not managing one of the most important modifiable
risk factors for a heart attack: high LDL-C2," said
Darryl Sleep, M.D., senior vice
president of Global Medical and chief medical officer at Amgen.
"These data demonstrate the important role cardiologists play in
closely monitoring and managing LDL-C in high-risk patients, and
support recent professional guideline recommendations that call for
more intensive reduction of LDL-C to lower the risk of future CV
events in high-risk patients3,4."
New FOURIER Data Shows No Impact on Patient-Reported
Cognition Function
An additional analysis from the FOURIER
study presented at AHA reinforces the safety and efficacy of
intensive LDL-C lowering with Repatha in high-risk cardiovascular
disease (CVD) patients. The analysis evaluated the impact of
lowering LDL-C with Repatha on cognition as reported by patients
with stable CVD and found that the addition of Repatha to statin
therapy had no impact on reported everyday cognition function,
including in those with very low LDL-C levels.
PROFICIO Program
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 36 trials including more than 38,000 patients
worldwide.
Repatha Cardiovascular Outcomes (FOURIER) Study
Design
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 cardiovascular events. The primary endpoint was the
time to cardiovascular death, myocardial infarction, stroke,
hospitalization for unstable angina, or coronary revascularization.
The key secondary endpoint was 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 atherosclerotic cardiovascular disease 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.
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.5
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.6 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.
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CONTACT: Amgen, Thousand
Oaks
Trish Hawkins, 805-447-5631
(media)
Jessica Akopyan, 805-447-0974
(media)
Arvind Sood, 805-447-1060
(investors)
References
- Jernberg T, et al. Eur Heart
J. 2015;36:1163-1170.
- Goldstein JL, et al. Arterioscler Thromb Vasc Biol.
2009;29(4):431-438.
- Mach F, et al. European Heart Journal. 2019;ehz455.
https://doi.org/10.1093/eurheartj/ehz455
- Grundy SM, et al. JACC. 2018; 1-80.
- Repatha Prescribing Information; Amgen, Thousand
Oaks, CA, 2018.
- World Health Organization. Cardiovascular diseases (CVDs) fact.
sheet. http://www.who.int/mediacentre/factsheets/fs317/en/.
Accessed November 2019.
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