THOUSAND OAKS, Calif.,
Feb. 21, 2017 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that the European
Commission (EC) has adopted a decision to change the
Repatha® (evolocumab) marketing authorization, approving
a new single-dose delivery option. The new automated mini-doser
(AMD) with a pre-filled cartridge is a hands-free device that
provides 420 mg of Repatha in a single injection per
administration. Repatha is the first proprotein convertase
subtilisin/kexin type 9 (PCSK9) inhibitor in Europe with the option of a single monthly
injection. Repatha is a human monoclonal antibody that blocks a
protein called PCSK9, which inhibits the body's natural system for
eliminating "bad" cholesterol (low-density lipoprotein cholesterol
or LDL-C) from the blood.1
"Amgen is committed to advancing care and improving the lives of
patients with cardiovascular disease," said Sean E. Harper, M.D., executive vice president
of Research and Development at Amgen. "We are proud to bring
this dosing alternative to patients in Europe, providing another option for them to
incorporate Repatha into their cardiovascular care, with less
frequent and hands-free administration."
Approval from the EC grants a change to the centralized
marketing authorization with unified labeling in the 28 countries
that are members of the European Union
(EU). Norway, Iceland and Liechtenstein, as
members of the European Economic Area (EEA), will take
corresponding decisions on the basis of the decision of the EC. The
Repatha AMD will be available in Europe this year depending on reimbursement
requirements.
In 2015, Repatha was the first PCSK9 inhibitor to gain marketing
authorization in Europe as an
every-two-week or monthly dosing regimen. In Europe, Repatha is approved as an adjunct to
diet for the treatment of high cholesterol in combination with
statins or other lipid-lowering therapies in patients unable to
control their LDL-C with maximally tolerated statin doses, or alone
or in combination with other lipid-lowering therapies in patients
who are statin intolerant or for whom a statin is contraindicated.
Repatha is also approved in combination with other lipid-lowering
agents in patients with homozygous familial hypercholesterolemia
(age 12 and over). The effect of Repatha on cardiovascular
morbidity and mortality has not yet been determined.
The U.S. Food and Drug Administration approved the single 420 mg
monthly injection option on July 11,
2016, as the Pushtronex™ system for use with Repatha
(on-body infusor with prefilled cartridge).
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
The Repatha cardiovascular outcomes trial (FOURIER) 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
Repatha cardiovascular outcomes study were announced by Amgen in
February 2017. Detailed results from
the Repatha cardiovascular outcomes study will be presented at the
American College of Cardiology 66th Annual Scientific
Session (ACC.17) in Washington,
D.C., March 17-19, 2017.
Repatha is approved in more than 40 countries, including the
U.S., Japan, Canada and in all 28 countries that are
members of the EU. Applications in other countries are pending.
Important EU Product Information
In Europe Repatha is approved for use in:
Hypercholesterolemia and mixed dyslipidemia
Repatha is
indicated in adults with primary hypercholesterolemia (heterozygous
familial and non-familial) or mixed dyslipidemia, as an adjunct to
diet:
- in combination with a statin or statin with other lipid
lowering therapies in patients unable to reach LDL-C goals with the
maximum tolerated dose of a statin or,
- alone or in combination with other lipid-lowering therapies in
patients who are statin-intolerant, or for whom a statin is
contraindicated.
Homozygous familial hypercholesterolemia
Repatha is
indicated in adults and adolescents aged 12 years and over with
homozygous familial hypercholesterolemia in combination with other
lipid-lowering therapies.
The effect of Repatha on cardiovascular morbidity and mortality
has not yet been determined.
Posology
Primary hypercholesterolemia and mixed
dyslipidemia in adults
The recommended dose of Repatha is either 140 mg every two weeks
or 420 mg once monthly; both doses are clinically equivalent.
Homozygous familial hypercholesterolemia in adults and
adolescents aged 12 years and over
The initial recommended
dose is 420 mg once monthly. After 12 weeks of treatment, dose
frequency can be up-titrated to 420 mg once every 2 weeks if a
clinically meaningful response is not achieved. Patients on
apheresis may initiate treatment with 420 mg every two weeks to
correspond with their apheresis schedule.
Important Safety Information
This medicinal product is
subject to additional monitoring. This will allow quick
identification of new safety information. Healthcare professionals
are asked to report any suspected adverse reactions.
Contraindications: Hypersensitivity to the active
substance or to any of the excipients.
Special Warnings and Precautions: Renal
impairment: Patients with severe renal impairment (defined as
eGFR < 30 mL/min/1.73 m2) have not been
studied. Repatha should be used with caution in patients with
severe renal impairment. Hepatic impairment: In patients with
moderate hepatic impairment, a reduction in total evolocumab
exposure was observed that may lead to a reduced effect on LDL‑C
reduction. Therefore, close monitoring may be warranted in these
patients. Patients with severe hepatic impairment (Child-Pugh C)
have not been studied. Repatha should be used with caution in
patients with severe hepatic impairment. Dry natural
rubber: The needle cover of the glass pre-filled syringe and
of the pre-filled pen is made from dry natural rubber (a derivative
of latex), which may cause allergic reactions. Sodium
content: Repatha contains less than 1 mmol sodium (23 mg) per
dose, i.e. it is essentially 'sodium-free'.
Interactions: No formal drug-drug interaction
studies have been conducted for Repatha. No studies on
pharmacokinetic and pharmacodynamics interaction between Repatha
and lipid-lowering drugs other than statins and ezetimibe have been
conducted.
Fertility, Pregnancy and Lactation: There are no or
limited amount of data from the use of Repatha in pregnant women.
Repatha should not be used during pregnancy unless the clinical
condition of the woman requires treatment with evolocumab. It is
unknown whether evolocumab is excreted in human milk. A risk to
breastfed newborns/infants cannot be excluded. No data on the
effect of evolocumab on human fertility are
available.
Undesirable Effects: The following common
(> 1/100 to < 1/10) adverse reactions have been reported
in pivotal, controlled clinical studies: influenza,
nasopharyngitis, upper respiratory tract infection, rash, nausea,
back pain, arthralgia, injection site reactions. Please consult
the SmPC for a full description of undesirable
effects.
Pharmaceutical Precautions: Store in a refrigerator
(2 degrees C – 8 degrees C). Do not freeze. Keep the
pre-filled syringe or the pre-filled pen in the original carton in
order to protect from light. If removed from the refrigerator,
Repatha may be stored at room temperature (up to 25 degrees C) in
the original carton and must be used within 1 month.
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 U.S. 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 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
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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
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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)
Amgen, Europe
Bridget Mullahy, +41 41 369 0452
Emma Gilbert, +41 41 369 2542
References
- Repatha® European Commission Summary of Product
Characteristics.
- World Health Organization. Cardiovascular diseases (CVDs) fact
sheet. http://www.who.int/mediacentre/factsheets/fs317/en/.
Accessed November 2016.
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SOURCE Amgen