THOUSAND OAKS, Calif.,
Aug. 27, 2015 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and
Drug Administration (FDA) has approved a new cholesterol-lowering
medication, Repatha™ (evolocumab) Injection. Repatha
is a human monoclonal antibody that inhibits proprotein convertase
subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's
ability to remove low-density lipoprotein cholesterol (LDL-C), or
"bad" cholesterol, from the blood.1
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), who require additional lowering of
LDL-C. The effect of Repatha on cardiovascular morbidity and
mortality has not been determined.
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"We are excited about today's approval of Repatha in the U.S. as
patients and physicians will now have a new treatment option to
lower LDL cholesterol," said Sean E. Harper, M.D., executive
vice president of Research and Development at Amgen. "Data
from key clinical studies have shown that Repatha significantly
reduces LDL cholesterol in patients who have not been able to lower
their LDL cholesterol through diet and statins alone. At Amgen, we
are committed to improving the lives of patients and
are inspired by the potential for Repatha to aid in the global
fight against one of the major risk factors for cardiovascular
disease."
Elevated LDL-C is an abnormality of cholesterol and/or fats in
the blood.2,3 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.4,5 Familial hypercholesterolemia is caused by
genetic mutations that lead to high levels of LDL-C at an early
age.6 It is estimated that one million people in the
U.S. have FH (heterozygous and homozygous forms), yet less than one
percent are diagnosed.7
"Through PCSK9 inhibition, evolocumab substantially reduces LDL
or 'bad' cholesterol, a well-validated, modifiable risk factor for
cardiovascular disease," said Marc
Sabatine, M.D., M.P.H., chairman of the TIMI Study
Group, the Lewis Dexter, MD Distinguished Chair in Cardiovascular
Medicine at Brigham and Women's Hospital, and professor
of medicine, Harvard Medical School,
Boston. "Many patients still
require further LDL cholesterol lowering and evolocumab now offers
an important new treatment option for them."
In Phase 3 trials, adding Repatha to background lipid-lowering
therapy that included statins resulted in intensive reductions in
LDL-C levels with favorable effects on other lipid parameters. In
patients with clinical ASCVD or HeFH, Repatha reduced LDL-C by
approximately 54 to 77 percent compared with placebo.8
In a pivotal Phase 3 trial, 90 percent of clinical ASCVD patients
who received Repatha in addition to maximum doses of statins
achieved a LDL-C level less than 70 mg/dL.5 In patients
with HoFH, Repatha reduced LDL-C by approximately 30 percent
compared with placebo.8
Repatha is generally well-tolerated with an established safety
profile. The most common adverse reactions that occurred in greater
than 5 percent of the Repatha group, and more frequently than in
the placebo group, were nasopharyngitis, upper respiratory tract
infection, influenza, back pain and injection site
reactions.8
Repatha is available as a single-use 140 mg prefilled
SureClick® autoinjector or prefilled syringe that
patients can self-administer at the recommended dose for adults of
140 mg every two weeks or 420 mg once a month. For adults with
HoFH, the recommended dose is 420 mg once a month. Amgen will
continue discussions with the FDA regarding the 420 mg every two
weeks dosing for HoFH patients.
The U.S. Wholesale Acquisition Cost (WAC) price of Repatha is
$542.31 for one 140 mg single-use
prefilled SureClick autoinjector or prefilled syringe, or
$14,100 annually for the every two
weeks administration. For the monthly 420 mg administration, Amgen
plans to make a single injection monthly dosing option available
next year. Until then, Amgen anticipates monthly administration
predominately for HoFH patients. 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.
"Amgen is sensitive to the concerns of payers around cost,
budget predictability and paying for value," said Anthony C. Hooper, executive vice president
of Global Commercial Operations at Amgen. "We are confident in
the ability of Repatha to demonstrate real-world effectiveness and
value based on intensive LDL cholesterol reductions, and we will be
working with payers and other purchasers to provide innovative
pricing programs linking the net price of Repatha to the expected
LDL cholesterol reductions and anticipated appropriate patient
utilization. By partnering with payers to implement these programs,
we can help ensure that all appropriate patients who could benefit
from Repatha will have access to this important new therapy."
Amgen is committed to providing personalized support services
for patients and providers in the U.S. through its
RepathaReady™ program.
RepathaReady is a comprehensive suite of services to help
patients and providers, including one or more months of free
Repatha through the Repatha Patient Start Program while insurance
coverage is pending; the Repatha $5
co-pay card for eligible commercial patients; insurance coverage
support; and injection training.
Amgen also provides patient assistance for its medicines
marketed in the U.S. in a variety of ways, including free medicines
through The Safety Net Foundation for qualifying individuals with
no or limited drug coverage.
Repatha is expected to be available in the U.S. next week.
Today's U.S. approval of Repatha follows the marketing
authorization of Repatha in Europe, which was announced on July 21, 2015.
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 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.8
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 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 recurrent
cardiovascular events in patients with high cholesterol and
clinically evident cardiovascular disease and completed patient
enrollment in June 2015. Results from
the approximately 27,500-patient FOURIER study are expected no
later than 2017 (event-driven).
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
Limitations of Use
The effect of Repatha on cardiovascular morbidity and mortality has
not been determined.
Important Safety Information
Repatha™ is
contraindicated in patients with a history of a serious
hypersensitivity reaction to Repatha. 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.
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, included:
Local injection site reactions that 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 4.6% 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 1609
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%).
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%).
Repatha is a human monoclonal antibody. As with all therapeutic
proteins, there is a potential for immunogenicity with Repatha.
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.9 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.
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 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 (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
Aug. 27,
2015, 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
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. 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 business may be impacted by
government investigations, litigation and products liability
claims. We depend on third parties for a significant portion of our
manufacturing capacity for the supply of certain of our current and
future products and limits on supply may constrain sales of certain
of our current products and product candidate development.
In addition, sales of our products are affected by the
reimbursement policies imposed by third-party payors, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
healthcare cost containment as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others'
regulations and reimbursement policies may affect the development,
usage and pricing of our products. In addition, we compete with
other companies with respect to some of our marketed products as
well as for the discovery and development of new products. We
believe that some of our newer products, product candidates or new
indications for existing products, may face competition when and as
they are approved and marketed. Our products may compete against
products that have lower prices, established reimbursement,
superior performance, are easier to administer, or that are
otherwise competitive with our products. In addition, while we
routinely obtain patents for our products and technology, the
protection offered by our patents and patent applications may be
challenged, invalidated or circumvented by our competitors and
there can be no guarantee of our ability to obtain or maintain
patent protection for our products or product candidates. We cannot
guarantee that we will be able to produce commercially successful
products or maintain the commercial success of our existing
products. Our stock price may be affected by actual or perceived
market opportunity, competitive position, and success or failure of
our products or product candidates. Further, the discovery of
significant problems with a product similar to one of our products
that implicate an entire class of products could have a material
adverse effect on sales of the affected products and on our
business and results of operations. Our efforts to integrate the
operations of companies we have acquired may not be successful. We
may experience difficulties, delays or unexpected costs and not
achieve anticipated benefits and savings from our ongoing
restructuring plan. Our business performance could affect or
limit the ability of our Board of Directors to declare a dividend
or their ability to pay a dividend or repurchase our common
stock.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Trish Hawkins, 805-447-5631
(media)
Arvind Sood, 805-447-1060
(investors)
References
- Amgen Data on File, Investigator Brochure.
- 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 August 2015.
- 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.
- Amgen Data on File.
- National Human Genome Research Institute. Learning About
Familial Hypercholesterolemia. http://www.genome.gov/25520184.
Accessed August 2015.
- 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.
- RepathaTM U.S. Prescribing Information. Amgen.
- World Health Organization. Cardiovascular diseases (CVDs) fact
sheet. http://www.who.int/mediacentre/factsheets/fs317/en/.
Accessed August 2015.
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SOURCE Amgen