THOUSAND OAKS, Calif.,
Feb. 4, 2016 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that the Phase 3
GAUSS-3 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in
Statin Intolerant Subjects-3) trial evaluating Repatha®
(evolocumab) in patients with high cholesterol who cannot tolerate
statins met its co-primary endpoints: mean percent reductions from
baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 22
and 24, and the percent reduction from baseline in LDL-C at week
24. The mean percent reductions in LDL-C, or "bad" cholesterol,
compared to ezetimibe, were consistent with results observed in the
12-week Phase 2 GAUSS-1 and Phase 3 GAUSS-2 trials.
"The positive results from the GAUSS-3 study contribute to the
growing body of evidence supporting Repatha as an innovative
treatment option for patients who have not been able to adequately
lower their LDL cholesterol through diet and statins alone," said
Sean E. Harper, M.D., executive vice
president of Research and Development at Amgen. "Many patients with
high LDL cholesterol are unable to tolerate effective doses of
statins, and the findings from the rigorously-designed GAUSS-3
study confirm the results in the previous GAUSS studies. We look
forward to exploring these data further."
GAUSS-3 is a three-part trial that is evaluating the safety,
tolerability and efficacy of Repatha, an injectable proprotein
convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in patients
with high cholesterol who could not tolerate statins due to
muscle-related side effects (MRSE). The active-controlled part of
the trial evaluated the effect of 24 weeks of treatment with
Repatha compared to ezetimibe on percent change from baseline in
LDL-C.
In the GAUSS-3 trial there were no new safety findings. The most
common adverse events that occurred in greater than 5 percent of
patients in the Repatha group were myalgia, nasopharyngitis, muscle
spasms, arthralgia, pain in extremity, fatigue, headache and back
pain.
The full data results from the Phase 3 GAUSS-3 trial will be
submitted to a future medical conference and for publication.
About Repatha®
(evolocumab)
Repatha® (evolocumab) is a
human monoclonal antibody that inhibits proprotein convertase
subtilisin/kexin type 9 (PCSK9).1 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.1
GLAGOV, the intravascular ultrasound study, is underway to
determine the effect of Repatha on coronary atherosclerosis in
approximately 950 patients undergoing cardiac catheterization to
test the hypothesis of robust LDL-C reduction leading to a
reduction or a change in the build-up of plaque in the arteries.
Results from the GLAGOV study are expected in the second half of
2016.
The FOURIER outcomes trial is designed to evaluate whether
treatment with Repatha in combination with statin therapy, compared
to placebo plus statin therapy, reduces the risk of cardiovascular
events in patients with high cholesterol and clinically evident
cardiovascular disease, and completed patient enrollment
in June 2015. Top-line results from the approximately
27,500-patient event-driven FOURIER study are anticipated in the
second half of 2016.
Repatha is approved in the United
States, Japan, Canada, Australia, Kuwait, and in all 28 countries that are
members of the European Union as well as in Norway, Iceland and Liechtenstein. Applications in other countries
are pending.
Important U.S. Product
Information
Repatha® is indicated as an
adjunct to diet and:
- Maximally tolerated statin therapy for treatment of adults with
heterozygous familial hypercholesterolemia (HeFH) or clinical
atherosclerotic cardiovascular disease (ASCVD), who require
additional lowering of low-density lipoprotein cholesterol
(LDL-C)
- 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 effect of Repatha® on cardiovascular
morbidity and mortality has not been determined.
The safety and effectiveness of Repatha® have
not been established in pediatric patients with HoFH who are
younger than 13 years old.
The safety and effectiveness of Repatha® have
not been established in pediatric patients with primary
hyperlipidemia or HeFH.
Important Safety Information
Contraindication: Repatha® is
contraindicated in patients with a history of a serious
hypersensitivity reaction to Repatha®.
Allergic reactions: Hypersensitivity reactions (e.g.
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 Repatha®-treated patients and more common
than placebo) were: nasopharyngitis, upper respiratory tract
infection, influenza, back pain, and injection site reactions.
In a 52-week trial, adverse reactions led to discontinuation of
treatment in 2.2% of Repatha®-treated patients and 1% of
placebo-treated patients. The most common adverse reaction that led
to Repatha® treatment discontinuation and occurred
at a rate greater than placebo was myalgia (0.3% versus 0% for
Repatha® and placebo, respectively).
Adverse 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. The proportions of patients who
discontinued treatment due to local injection site reactions in
Repatha®-treated patients and placebo-treated patients
were 0.1% and 0%, respectively.
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%).
Neurocognitive events were reported in less than or equal to
0.2% in Repatha®-treated and placebo-treated
patients.
In a pool of placebo- and active-controlled trials, as well as
open-label extension studies that followed them, a total of 1,988
patients treated with Repatha® had at least one
LDL-C value <25 mg/dL. Changes to background lipid-altering
therapy were not made in response to low LDL-C values, and
Repatha® dosing was not modified or interrupted on
this basis. Although adverse consequences of very low LDL-C were
not identified in these trials, the long-term effects of very low
levels of LDL-C induced by Repatha® are
unknown.
Musculoskeletal adverse reactions were reported in 14.3% of
Repatha®-treated patients and 12.8% of placebo-treated
patients. The most common adverse reactions that occurred at a rate
greater than placebo were back pain (3.2% versus 2.9% for
Repatha® and placebo, respectively), arthralgia
(2.3% versus 2.2%), and myalgia (2.0% versus 1.8%).
Homozygous Familial Hypercholesterolemia (HoFH): In
49 patients with homozygous familial hypercholesterolemia studied
in a 12-week, double-blind, randomized, placebo-controlled trial,
33 patients received 420 mg of
Repatha® subcutaneously once monthly. The adverse
reactions that occurred in at least 2 (6.1%)
Repatha®-treated patients and more frequently than in
placebo-treated patients, included upper respiratory tract
infection (9.1% versus 6.3%), influenza (9.1% versus 0%),
gastroenteritis (6.1% versus 0%), and nasopharyngitis (6.1% versus
0%).
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 Cardiovascular
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.2 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 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.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
Amgen Forward-Looking Statements
This news release
contains forward-looking statements that are based on management's
current expectations and beliefs and are subject to a number of
risks, uncertainties and assumptions that could cause actual
results to differ materially from those described. All statements,
other than statements of historical fact, are statements that could
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regulatory or clinical results or practices, customer and
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outcomes 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 (SEC) reports filed by Amgen, including
Amgen's most recent annual report on Form 10-K and any subsequent
periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's
most recent Forms 10-K, 10-Q and 8-K for additional information on
the uncertainties and risk factors related to our business. Unless
otherwise noted, Amgen is providing this information as of
Feb. 4, 2016, and expressly disclaims
any duty to update information contained in this news release.
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
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, preclinical results do not
guarantee safe and effective performance of product candidates in
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sometimes, even adequately modeled by computer or cell culture
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to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar
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believe that some of our newer products, product candidates or new
indications for existing products, may face competition when and as
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superior performance, are easier to administer, or that are
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The scientific information discussed in this news release
relating to new indications is preliminary and investigative and is
not part of the labeling approved by the U.S. Food and Drug
Administration or European Commission for the products. The
products are not approved for the investigational use(s) discussed
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regarding the safety or effectiveness of the products for these
uses.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis: 805-447-3008
(media)
Kristen Neese: 805-313-8267
(media)
Arvind Sood: 805-447-1060
(investors)
References
1. Amgen Data on File,
Investigator Brochure.
2. World Health Organization. Cardiovascular
diseases (CVDs) fact sheet.
http://www.who.int/mediacentre/factsheets/fs317/en/. Accessed
January 2016.
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