Studies Showed Sustained Reduction in LDL-C
With no new Safety Findings
The Combined Studies Evaluated Safety and
Tolerability of Repatha in More Than 6,600 Patients for Over Five
Years After Completing the Phase 3 FOURIER Trial
Repatha is the Longest Studied PCSK9i
THOUSAND
OAKS, Calif., April 27,
2022 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
announced top-line results from two
Repatha® (evolocumab) open label extension (OLE)
studies to the Phase 3 FOURIER cardiovascular outcomes trial. The
studies were designed to assess the long-term safety and
tolerability of Repatha over five years in adults with clinically
evident atherosclerotic cardiovascular disease.
The FOURIER-OLE (Further
cardiovascular OUtcomes Research with
PCSK9 Inhibition in Subjects with Elevated
– Risk-Open Label Extension) studies were composed of study
20130295 (NCT02867813) with 5,035 patients enrolled in Eastern Europe and the United States and study 20160250
(NCT03080935) with 1,600 patients enrolled in Western
Europe. Both studies showed that Repatha, administered at 140
mg every two weeks or 420 mg monthly, was safe and well-tolerated.
In the OLE studies, patients received Repatha for approximately 5
years, with some patients receiving Repatha for up to 8 1/2 years
in aggregate across the FOURIER and OLE studies. No new long-term
safety findings were observed.
In addition, medically significant and sustained reduction in
low-density lipoprotein cholesterol (LDL-C) levels were observed,
with more than 85 percent of patients achieving an LDL-C level of
<40 mg/dL during the OLE period.
"The combined results from these studies reinforce the
well-established safety profile of Repatha with long-term use in
lowering LDL-C," said David M. Reese, M.D., executive vice
president of Research and Development at Amgen. "As the PCSK9i
leader, with more than one million patients worldwide who have
received Repatha, we are extremely encouraged by the sustained
benefit of this effective medicine for patients with cardiovascular
disease who still struggle to get their LDL-C level below
recommended goals."
Other study measures included exploratory analyses of
non-high-density lipoprotein cholesterol, apolipoprotein B, total
cholesterol, Lipoprotein(a), triglycerides, high-density
lipoprotein cholesterol, very-low-density lipoprotein cholesterol,
and apolipoprotein A-1 levels, as well as cardiovascular events of
interest.
Detailed study results will be shared with regulatory
authorities and submitted for presentation at an upcoming medical
congress later this year. Prolonged LDL-C reduction with Repatha is
also being studied in the ongoing VESALIUS-CV (NCT03872401)
outcomes trial.
Repatha® Cardiovascular Open-Label Extension
(FOURIER-OLE) Study Design
FOURIER (20110118) was a
randomized placebo-controlled study of evolocumab, in patients with
clinically evident atherosclerotic CVD on stable effective statin
therapy. FOURIER-OLE (Further
cardiovascular OUtcomes Research with
PCSK9 Inhibition in Subjects with Elevated
– Risk-Open Label Extension) were multicenter, open-label
extension (OLE) studies designed to assess the extended long-term
safety of evolocumab in subjects who completed the FOURIER study
(20110118). The FOURIER-OLE is composed of studies 20130295 and
20160250, which enrolled 5,035 and 1,600 subjects who completed
FOURIER study (20110118) to receive open-label evolocumab and were
followed up for a median of 5 and 4.6 years,
respectively.
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.
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 2021, Amgen was named one of the 25 World's Best Workplaces™ by
Fortune and Great Place to Work™ and one of the 100 most
sustainable companies in the world by Barron's.
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.
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.
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 (LDLC)-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
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collaborations, with any other company (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, or the Teneobio, Inc. acquisition,
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No forward-looking statement can be guaranteed and actual
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CONTACT: Amgen, Thousand Oaks
Michael Strapazon, 805-313-5553
(media)
Jessica Akopyan, 805-440-5721
(media)
Arvind Sood, 805-447-1060
(investors)
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