THOUSAND OAKS, Calif.,
July 11, 2016 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and
Drug Administration (FDA) has approved the Repatha®
(evolocumab) Pushtronex™ system (on-body infusor
with prefilled cartridge), a new, monthly single-dose
administration option.1 The Pushtronex system is a
hands-free device designed to provide 420 mg of Repatha in a single
dose. Repatha is a human monoclonal antibody that blocks a protein
called proprotein convertase subtilisin/kexin type 9 (PCSK9), which
inhibits the body's natural system for eliminating "bad"
cholesterol (low-density lipoprotein cholesterol or LDL-C) from the
blood.1 Repatha is the first and only PCSK9 inhibitor to
offer a monthly single-dose delivery option.
"The Pushtronex system exemplifies Amgen's continued innovation
and commitment to patients," said Sean E.
Harper, M.D., executive vice president of Research and
Development at Amgen. "Repatha is the only PCSK9 inhibitor with an
approved monthly dose, and now the only one with a monthly
single-dose administration. The FDA approval of the Pushtronex
system offers another delivery option to patients who need the
additional LDL cholesterol lowering that Repatha can provide."
In the U.S., Repatha is indicated as an adjunct to diet and
maximally tolerated statin therapy for the treatment of adults with
heterozygous familial hypercholesterolemia (HeFH) or clinical
atherosclerotic cardiovascular disease (ASCVD), who require
additional lowering of LDL-C; and as an adjunct to diet and other
LDL-lowering therapies for the treatment of patients with
homozygous familial hypercholesterolemia (HoFH) over age 13, who
require additional lowering of LDL-C.1 The effect of
Repatha on cardiovascular morbidity and mortality has not been
determined.
The new, single-use device was developed in collaboration with
West Pharmaceutical Services, based on the SmartDose®
technology platform, to provide patients with an additional dosing
option for Repatha treatment. The device adheres to the body and
patients are hands free during administration. Patients are able to
perform moderate physical activities (such as walking, reaching or
bending) as the 420 mg of Repatha is delivered subcutaneously.
The U.S. Wholesale Acquisition Cost (WAC) price of Repatha is
$14,100 annually, whether it is
delivered monthly via Pushtronex system or every two weeks via
SureClick® autoinjector. Actual costs to patients,
payers and health systems are anticipated to be lower as WAC
pricing does not reflect discounts or rebates. Out-of-pocket costs
to patients will vary depending on insurance status and eligibility
for patient assistance. The Pushtronex system will be available to
patients in the U.S. in early August.
Elevated LDL-C is an abnormality of cholesterol and/or fats in
the blood and is recognized as a major risk factor for
cardiovascular disease.2-5 In the U.S., there are
approximately 11 million people with ASCVD and/or familial
hypercholesterolemia (FH) who have uncontrolled levels of LDL-C
over 70 mg/dL, despite treatment with statins or other
cholesterol-lowering therapies.6,7 FH is caused by
genetic mutations that lead to high levels of LDL-C at an early
age.8 It is estimated that one million people in the
U.S. have FH, yet less than one percent are
diagnosed.9
About Repatha®
(evolocumab)
Repatha® (evolocumab) 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.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 first
quarter of 2017.
Repatha is approved in 43 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 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.10 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 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.
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
statements that could be deemed forward-looking statements,
including estimates of revenues, operating margins, capital
expenditures, cash, other financial metrics, expected legal,
arbitration, political, regulatory or clinical results or
practices, customer and prescriber patterns or practices,
reimbursement activities and 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 reports filed
by Amgen, including our most recent annual report on Form 10-K and
any subsequent periodic reports on Form 10-Q and 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 statements contained in this document as
a result of new 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 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 humans. The complexity of the
human body cannot be perfectly, or sometimes, even adequately
modeled by computer or cell culture systems or animal models. The
length of time that it takes for us to complete clinical trials and
obtain regulatory approval for product marketing has in the past
varied and we expect similar variability in the future. Even when
clinical trials are successful, regulatory authorities may question
the sufficiency for approval of the trial endpoints we have
selected. We develop product candidates internally and through
licensing collaborations, partnerships and joint ventures. Product
candidates that are derived from relationships may be subject to
disputes between the parties or may prove to be not as effective or
as safe as we may have believed at the time of entering into such
relationship. Also, we or others could identify safety, side
effects or manufacturing problems with our products after they are
on the market.
Our results may be affected by our ability to successfully
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current and future products, sales growth of recently launched
products, competition from other products including biosimilars,
difficulties or delays in manufacturing our products and global
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may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
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Further, while we routinely obtain patents for our products and
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intellectual property litigation. We perform a substantial amount
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of new products. Further, some raw materials, medical devices and
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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
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CONTACT: Amgen, Thousand
Oaks
Kristen Davis: 805-447-3008
(media)
Kristen Neese: 805-313-8267
(media)
Arvind Sood: 805-447-1060
(investors)
References
- Repatha® U.S. Prescribing
Information. Amgen.
- World Health Organization. Quantifying Selected Major Risks to
Health. In: The World Health Report 2002 - Reducing Risks,
Promoting Healthy Life. Geneva. 2002:49-97.
- Merck Manuals website.
http://www.merckmanuals.com/professional/endocrine_and_metabolic_disorders/lipid_disorders/dyslipidemia.html.
Accessed May 2016.
- American Heart Association (2014). Why Cholesterol Matters.
http://www.heart.org/HEARTORG/Conditions/Cholesterol/WhyCholesterolMatters/Why-Cholesterol-Matters_UCM_001212_Article.jsp.
Accessed May 2016.
- World Health Organization. Global Status Report on
Noncommunicable Diseases 2014. Geneva, 2014.
- Amgen Data on File.
- Centers for Disease Control and Prevention. Vital signs:
prevalence, treatment, and control of high levels of low-density
lipoprotein cholesterol. United
States, 1999–2002 and 2005–2008. MMWR.
2011;60(4):109–14.
- National Human Genome Research Institute. Learning About
Familial Hypercholesterolemia. http://www.genome.gov/25520184.
Accessed May 2016.
- Nordestgaard BG, Chapman MJ, Humphries SE, et al. Familial
Hypercholesterolaemia is Underdiagnosed and Undertreated in the
General Population: Guidance for Clinicians to Prevent Coronary
Heart Disease. Eur Heart J. 2013;34:3478-3490.
- World Health Organization. Cardiovascular diseases (CVDs) fact
sheet. http://www.who.int/mediacentre/factsheets/fs317/en/.
Accessed May 2016.
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