THOUSAND OAKS, Calif.,
Aug. 22, 2016 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced that it will present 11 abstracts at
the upcoming European Society of Cardiology (ESC) Congress 2016,
being held Aug. 27-31 in Rome.
Abstracts include data evaluating Repatha®
(evolocumab), a proprotein convertase subtilisin/kexin type 9
(PCSK9) inhibitor for the treatment of patients with high
cholesterol, across ESC/European Atherosclerosis Society (EAS)
cardiovascular risk subgroups, as well as the long-term efficacy
and safety of Repatha treatment in patients with the genetic
condition heterozygous familial hypercholesterolemia (HeFH).
Additionally, an analysis of familial hypercholesterolemia (FH)
diagnosis and prevalence will be highlighted as a Rapid Fire
Abstract.
"Amgen is committed to further advancing our scientific
understanding of Repatha and how it can benefit patients with
cardiovascular disease and hypercholesterolemia," said Sean E. Harper, M.D., executive vice president
of Research and Development at Amgen. "The Repatha clinical
development program has clearly demonstrated the medicine's ability
to deliver meaningful LDL cholesterol reduction in appropriate
patients. The findings presented at ESC 2016, alongside the six new
clinical trials that have begun in the last year, will better
define the benefit of Repatha for the many patients who continue to
struggle with hypercholesterolemia."
Data from Amgen's Center for Observational Research will also be
presented, including a presentation on the trends of high-intensity
statin therapy after myocardial infarction (MI), as well as
research on recurrent coronary heart disease and mortality risk
following MI, in medically-managed patients. In addition, Amgen
Global Health Economics data from a multi-ethnic study will be
presented on the residual risks of atherosclerotic cardiovascular
disease (ASCVD) in statin-treated adults.
Amgen-sponsored abstracts at ESC Congress 2016 include:
Repatha
- Efficacy of evolocumab in patients across ESC/EAS CV risk
subgroups
Abstract 061051, Poster Presentation,
Sunday, Aug. 28, 8:30 a.m.-12:30 p.m. CET (Poster Area)
- Pharmacokinetics and pharmacodynamics of evolocumab in
patients with renal impairment
Abstract 055112, Poster
Presentation, Sunday, Aug. 28,
8:30 a.m.-12:30 p.m. CET (Poster
Area)
- Long-term safety, tolerability, and efficacy of evolocumab
in patients with heterozygous familial
hypercholesterolaemia
Abstract 060215, Poster Presentation,
Sunday, Aug. 28, 8:30 a.m.-12:30 p.m. CET (Poster Area)
- Factorial effects of evolocumab and atorvastatin on
lipoprotein metabolism: the FLOREY stable isotope study
Abstract 061052, Poster Presentation, Monday, Aug. 29, 8:30
a.m.-12:30 p.m. CET (Poster Area)
Observational Research
- Familial hypercholesterolaemia diagnosis: a case of missed
opportunity
Abstract 060852, Rapid Fire Abstract,
Saturday, Aug. 27, 11:27-11:45 a.m. CET (Agora 2- Poster Area)
- Trends in high-intensity statin therapy after myocardial
infarction, 2011-2014
Abstract 060217, Poster Presentation,
Sunday, Aug. 28, 8:30 a.m.-12:30 p.m. CET (Poster Area)
- Increased recurrent coronary heart disease and mortality
risk among intensive medically managed patients following
myocardial infarction
Abstract 061617, Poster Presentation,
Monday, Aug. 29, 8:30 a.m.-12:30 p.m. CET (Poster Area)
- Statin use and dose by low-density lipoprotein cholesterol
level in U.S. commercially insured patients with type 2
diabetes
Abstract 061615, Moderated Poster Presentation,
Tuesday, Aug. 30, 10:12-10:19 a.m. CET (Moderated Poster Station -
Poster Area)
Health Economics
- Prevalence of patients with familial hypercholesterolemia
(FH) in the German cardiology office-based setting
Abstract
059510, Poster Presentation, Monday, Aug.
29, 8:30 a.m.-12:30 p.m. CET
(Poster Area)
- Contemporary low-density lipoprotein-cholesterol (LDL-C)
levels and patient characteristics in 1000 high-risk patients
examined in German cardiology practices
Abstract 059515,
Poster Presentation, Monday, Aug. 29,
8:30 a.m.-12:30 p.m. CET (Poster
Area)
- Residual atherosclerotic cardiovascular disease risk in
statin-treated adults: the multi-ethnic study of
atherosclerosis
Abstract 061097, Moderated Poster
Presentation, Tuesday, Aug. 30,
10:40-10:47 a.m. CET (Moderated
Poster Station - Poster Area)
New Repatha Clinical Trials
The below list of
clinical trials have begun enrolling patients since Sept. 1, 2015:
- A Double-blind, Randomized Study in Diabetic Subjects With
Hyperlipidemia or Mixed Dyslipidemia
- Trial Assessing Efficacy, Safety and Tolerability of PCSK9
Inhibition in Paediatric Subjects With Genetic LDL Disorders
(HAUSER-RCT)
- A Study in Subjects With Type 2 Diabetes Mellitus With
Hypercholesterolemia/Mixed Dyslipidemia
- Effects of Proprotein Convertase Subtilisin/Kexin Type 9
(PCSK9) Inhibition on Arterial Wall Inflammation Study in Patients
With Elevated Lipoprotein(a) (Lp(a)). (ANITSCHKOW)
- Goal Achievement After Utilizing an Anti-PCSK9 Antibody in
Statin Intolerant Subjects-4
- Trial Assessing Evolocumab(AMG145) Compared to LDL-C Apheresis
in Subjects Receiving LDL-C Apheresis Prior to Study
Enrollment
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. The primary endpoint for
the FOURIER trial is major cardiovascular events defined as the
composite of cardiovascular death, myocardial infarction (MI),
stroke, hospitalization for unstable angina or coronary
revascularization. The key secondary end point is the composite of
cardiovascular death, MI or stroke. The trial is planned to
continue until at least 1,630 patients experience the secondary
endpoint, thereby providing 90 percent power to detect a relative
reduction of 15 percent in this endpoint. Top-line results from the
approximately 27,500-patient event-driven FOURIER study are
anticipated in first quarter of 2017.
Repatha is approved in 44 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 EU Product Information
Repatha®
is indicated in adults with primary hypercholesterolaemia
(heterozygous familial and non-familial) or mixed dyslipidaemia, 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.
Repatha® is indicated in adults and adolescents aged
12 years and over with homozygous familial hypercholesterolaemia in
combination with other lipid-lowering therapies.
The effect of Repatha® on cardiovascular
morbidity and mortality has not yet been determined.
Important EU 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.
Posology: The recommended dose for adults with primary
disease is either 140 mg every two weeks or 420 mg (the contents of
three pre-filled syringes) once a month; both doses are clinically
equivalent. For adults or children older than 12 years with
homozygous familial hypercholesterolemia, the initial recommended
dose is 420 mg once a month. If a response is not achieved after 12
weeks of treatment, the dose can be increased up to 420 mg every
two weeks. For more information, see the package leaflet.
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°C
– 8°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°C) in the original carton and must be
used within 1 week.
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
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No forward-looking statement can be guaranteed and actual
results may differ materially from those we project.
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Further, preclinical results do not guarantee safe and effective
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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
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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. Cardiovascular diseases (CVDs) fact
sheet. http://www.who.int/mediacentre/factsheets/fs317/en/.
Accessed July 2016.
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