Amarin Corporation plc (NASDAQ: AMRN), a pharmaceutical company
focused on improving cardiovascular health, today announced that
the European Society of Cardiology (ESC) and the European
Atherosclerosis Society (EAS) have updated their Clinical Practice
Guidelines for the Management of Dyslipidaemias. This 2019 update
incorporates findings from the REDUCE-IT™1,2 cardiovascular
outcomes study and includes the recommendation that icosapent
ethyl, 2g twice a day, should be considered for patients with
cardiovascular disease who have triglyceride levels 135 mg/dL to
499 mg/dL despite statin treatment, which places them at high risk
of cardiovascular events, such as heart attack, stroke or death.3
This new recommendation incorporates icosapent ethyl specifically.
Icosapent ethyl, studied in a series of clinical trials,
including the globally conducted REDUCE-IT study, was developed by
Amarin and is exclusively marketed by Amarin and its commercial
partners in capsule form under the brand name Vascepa® (icosapent
ethyl). In the United States, Vascepa is currently approved as an
adjunct to diet to reduce triglyceride levels in adult patients
with severe (≥500 mg/dL) hypertriglyceridemia. Amarin has submitted
a supplemental new drug application (sNDA) to the U.S. FDA for an
expansion of the Vascepa U.S. FDA label based on the landmark
REDUCE-IT results showing reduction of cardiovascular events in
high risk patients. The company plans to submit an application
seeking approval for icosapent ethyl in Europe for reducing
cardiovascular events before the end of 2019. A similar application
has already been submitted and is under priority review by Health
Canada.
ESC and EAS do not provide endorsements or any form of
certification for brand name commercial products. Accordingly, the
inclusion of icosapent ethyl in the Clinical Practice Guidelines
for the Management of Dyslipidaemias should not be understood as an
endorsement or approval by ESC or EAS of Vascepa.
“We are pleased by ESC and EAS’s acknowledgement of the
significance of the REDUCE-IT results as evidenced by their 2019
updates of the Clinical Practice Guidelines for the Management of
Dyslipidaemias,” says Craig B. Granowitz, M.D., Ph.D., senior vice
president and chief medical officer of Amarin. “Amarin believes
strongly in the potential for icosapent ethyl to be an important
treatment option for the millions of high-risk patients who are on
statin therapy with controlled cholesterol levels, yet have
elevated triglycerides and other cardiovascular risk factors. This
update comes just weeks after the American Heart Association issued
an advisory statement referencing REDUCE-IT and the cardiovascular
risk-lowering effects of icosapent ethyl and months after the
American Diabetes Association included the REDUCE-IT results as
part of its updates to the Standards of Medical Care in
Diabetes for 2019.4, [5] All of these updates further support
the use of icosapent ethyl as an important treatment option for
appropriate patients at high risk of cardiovascular events.”
Based on the results of REDUCE-IT, the 2019 updates to the
Clinical Practice Guidelines for the Management of Dyslipidaemias
specifically recommend that:
In high-risk (or above) patients with TG [triglycerides] levels
between 1.5 – 5.6 mmol/L (135-499 mg/dL) despite statin treatment,
n-3 PUFAs [polyunsaturated fatty acids] (icosapent ethyl 2x2 g/day)
should be considered with a statin.6
The ESC and EAS recommendation is classified as a IIa
recommendation denoting that icosapent ethyl should be considered
for treatment of such patients. The classification is a Level B
recommendation which reflects a relatively high weight of
scientific evidence under ESC and EAS standards. Such
recommendations are supported by the results of the REDUCE-IT
cardiovascular outcomes study.
In the United States, approximately 15 million people match the
criteria of the REDUCE-IT studied population, with triglycerides ≥
135 mg/dL and other cardiovascular risk factors, despite statin
treatment.7 About 25 percent of a representative sample survey of
more than 7,800 patients from 27 European countries with coronary
heart disease and controlled cholesterol levels had triglyceride
levels of 150 mg/dL or greater, illustrating the potential
pervasiveness of high-risk cardiovascular disease in Europe.8
“These updated guidelines from such prestigious organizations
reaffirm the importance of the REDUCE-IT findings to patients
globally, not only in enhancing care, but also in broadening
awareness of the need for treatment among patients who may have
their cholesterol controlled with a statin, but remain at risk
because of elevated triglycerides,” says Deepak L. Bhatt, M.D.,
M.P.H., executive director of Interventional Cardiovascular
Programs at Brigham and Women’s Hospital, professor of medicine at
Harvard Medical School, and principal investigator and steering
committee chair for REDUCE-IT. “Based on what we’re learning from
REDUCE-IT and the related guidance from ESC and EAS, I foresee the
beginning of a global change in clinical practice in how best to
treat patients with multifactorial risks of cardiovascular events
beyond cholesterol management.”
Amarin acknowledges the rigor with which the Clinical Practice
Guidelines for the Management of Dyslipidaemias are crafted and
approved by the ESC’s and EAS’s task force, which is comprised of
more than 15 leading professionals in the European Union who
specialize in the care of patients with dyslipidaemias.
The complete 2019 updates to the Clinical Practice Guidelines
for the Management of Dyslipidaemias can be accessed online by
clicking here.
About AmarinAmarin Corporation plc. is a
rapidly growing, innovative pharmaceutical company focused on
developing therapeutics to improve cardiovascular health. Amarin’s
product development program leverages its extensive experience in
polyunsaturated fatty acids and lipid science. Vascepa (icosapent
ethyl) is Amarin's first FDA-approved drug and is available by
prescription in the United States, Lebanon and the United Arab
Emirates. Amarin’s commercial partners are pursuing additional
regulatory approvals for Vascepa in Canada, China and the Middle
East. For more information about Amarin, visit
www.amarincorp.com.
REDUCE-IT™ StudyREDUCE-IT, an 8,179-patient
cardiovascular outcomes study, was completed in 2018. REDUCE-IT was
the first multinational cardiovascular outcomes study that
evaluated the effect of prescription pure EPA therapy as an add-on
to statins in patients with high cardiovascular risk who, despite
stable statin therapy, had elevated triglyceride levels (at least
135 mg/dL). A large portion of the male and female patients
enrolled in this outcomes study were diagnosed with type 2
diabetes.
More information on the REDUCE-IT study results can be found at
www.amarincorp.com.
About Cardiovascular DiseaseWorldwide,
cardiovascular disease (CVD) remains the #1 killer of men and
women. In the United States CVD leads to one in every three deaths
– one death approximately every 38 seconds – with annual treatment
cost in excess of $500 billion.9,[10]
Multiple primary and secondary prevention trials have
shown a significant reduction of 25% to 35% in the risk
of cardiovascular events with statin therapy,
leaving significant persistent residual risk despite the
achievement of target LDL-C levels.11
Beyond the cardiovascular risk associated with LDL-C, genetic,
epidemiologic, clinical and real-world data suggest that patients
with elevated triglycerides (TG) (fats in the blood), and TG-rich
lipoproteins, are at increased risk for cardiovascular disease.12,
13,[14],[15]
About Vascepa® (icosapent ethyl)
CapsulesVascepa (icosapent ethyl) capsules are a
single-molecule prescription product consisting of the omega-3 acid
commonly known as EPA in ethyl-ester form. Vascepa is not fish oil,
but is derived from fish through a stringent and complex
FDA-regulated manufacturing process designed to effectively
eliminate impurities and isolate and protect the single molecule
active ingredient from degradation. Vascepa, known in scientific
literature as AMR101, has been designated a new chemical entity by
the FDA. Amarin has been issued multiple patents internationally
based on the unique clinical profile of Vascepa, including the
drug’s ability to lower triglyceride levels in relevant patient
populations without raising LDL-cholesterol levels.
The FDA has not reviewed and opined on a supplemental new drug
application related to REDUCE IT. FDA has thus not reviewed the
information herein or determined whether to approve Vascepa for use
to reduce the risk of major adverse cardiovascular events in the
REDUCE-IT patient population
Indication and Usage Based on Current FDA-Approved Label (not
including REDUCE-IT results)
- Vascepa (icosapent ethyl) is indicated as an adjunct to diet to
reduce triglyceride (TG) levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia.
- The effect of Vascepa on the risk for pancreatitis and
cardiovascular mortality and morbidity in patients with severe
hypertriglyceridemia has not been determined.
Important Safety Information for Vascepa Based on Current
FDA-Approved Label (not including REDUCE-IT results) (Includes Data
from Two 12-Week Studies (n=622) (MARINE and ANCHOR) of Patients
with Triglycerides Values of 200 to 2000 mg/dL)
- Vascepa is contraindicated in patients with known
hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of
its components.
- In patients with hepatic impairment, monitor ALT and AST levels
periodically during therapy.
- Use with caution in patients with known hypersensitivity to
fish and/or shellfish.
- The most common reported adverse reaction (incidence >2% and
greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for
placebo). There was no reported adverse reaction >3% and greater
than placebo.
- Adverse events and product complaints may be reported by
calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088. Patients
receiving treatment with Vascepa and other drugs affecting
coagulation (e.g., anti-platelet agents) should be monitored
periodically.
- Patients should be advised to swallow Vascepa capsules whole;
not to break open, crush, dissolve, or chew Vascepa.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT
WWW.VASCEPA.COM.
Important Safety Information for Vascepa based on REDUCE-IT, as
previously reported in The New England Journal of Medicine
publication of the primary results of the REDUCE-IT
study:
- Excluding the major adverse cardiovascular events (MACE)
results described above, overall adverse event rates in REDUCE-IT
were similar across the statin plus Vascepa and the statin plus
placebo treatment groups.
- There were no significant differences between treatments in the
overall rate of treatment emergent adverse events or serious
adverse events leading to withdrawal of study drug.
- There was no serious adverse event (SAE) occurring at a
frequency of >2% which occurred at a numerically higher rate in
the statin plus Vascepa treatment group than in the statin plus
placebo treatment group.
- Adverse events (AEs) occurring in 5% or greater of patients and
more frequently with Vascepa than placebo were:
- peripheral edema (6.5% Vascepa patients versus 5.0% placebo
patients), although there was no increase in the rate of heart
failure in Vascepa patients
- constipation (5.4% Vascepa patients versus 3.6% placebo
patients), although mineral oil, as used as placebo, is known to
lower constipation, and
- atrial fibrillation (5.3% Vascepa patients versus 3.9% placebo
patients), although there were reductions in rates of cardiac
arrest, sudden death and myocardial infarctions observed in Vascepa
patients
- There were numerically more SAEs related to bleeding in the
statin plus Vascepa treatment group although overall rates were low
with no fatal bleeding observed in either group and no significant
difference in adjudicated hemorrhagic stroke or serious central
nervous system or gastrointestinal bleeding events between
treatments.
- In summary, Vascepa was well tolerated with a safety profile
generally consistent with clinical experience associated with
omega-3 fatty acids and current FDA-approved labeling of such
products.
Important Cautionary Information About These
Data Further REDUCE-IT data assessment and data
release could yield additional useful information to inform greater
understanding of the trial outcome. For example, detailed data
assessment by regulatory authorities, such as the FDA and Health
Canada, will continue and take several months to complete and
announce. The FDA advisory committee process and the final
evaluation by regulatory authorities of the totality of efficacy
and safety data from REDUCE-IT may include some or all of the
following, as well as other considerations: new information or
analyses affecting the degree of treatment benefit on studied
endpoints; study conduct and data robustness, quality, integrity
and consistency; additional safety data considerations and
risk/benefit considerations; and consideration of REDUCE-IT results
in the context of other clinical studies. Because regulatory
reviews are typically fluid and not definitive interactions between
sponsor and agency on individual elements of an application and
related information, Amarin does not plan to update investors on
ongoing communications with regulatory authorities. Amarin plans to
announce the final outcome of such regulatory reviews when
appropriate.
Forward-Looking StatementsThis press release
contains forward-looking statements, including statements regarding
the use of Vascepa to potentially help millions of patients. These
forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. Among the factors that
could cause actual results to differ materially from those
described or projected herein include the following: uncertainties
associated generally with research and development, clinical trials
and related regulatory reviews and approvals; the risk that data
interpretations or other information from third parties, the
regulatory review process, regulatory authorities and in connection
with an advisory committee could be made public that are negative
or may delay approval or limit Vascepa’s marketability; the risk
that special protocol assessment (SPA) agreements with the FDA are
not a guarantee that FDA will approve a product candidate; the risk
associated with the FDA's rescinding the REDUCE-IT SPA agreement;
the risk related to FDA advisory committee meetings; and the risk
that the FDA may not complete its review of the REDUCE-IT sNDA
within the timing expected. A further list and description of these
risks, uncertainties and other risks associated with an investment
in Amarin can be found in Amarin's filings with the U.S. Securities
and Exchange Commission, including its most recent Quarterly Report
on Form 10-Q. Existing and prospective investors are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Amarin undertakes no obligation
to update or revise the information contained in this press
release, whether as a result of new information, future events or
circumstances or otherwise.
Availability of Other Information About
AmarinInvestors and others should note that Amarin
communicates with its investors and the public using the company
website (www.amarincorp.com), the investor relations website
(investor.amarincorp.com), including but not limited to investor
presentations and investor FAQs, Securities and Exchange Commission
filings, press releases, public conference calls and webcasts. The
information that Amarin posts on these channels and websites could
be deemed to be material information. As a result, Amarin
encourages investors, the media, and others interested in Amarin to
review the information that is posted on these channels, including
the investor relations website, on a regular basis. This list of
channels may be updated from time to time on Amarin’s investor
relations website and may include social media channels. The
contents of Amarin’s website or these channels, or any other
website that may be accessed from its website or these channels,
shall not be deemed incorporated by reference in any filing under
the Securities Act of 1933.
Amarin Contact InformationInvestor
Inquiries:Elisabeth SchwartzInvestor RelationsAmarin
Corporation plcIn U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. SternSolebury TroutIn U.S.: +1 (646) 378-2992
lstern@soleburytrout.com
Media Inquiries:Gwen FisherCorporate
Communications Amarin Corporation plcIn U.S.: +1 (908) 325-0735
pr@amarincorp.com
References
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2 Bhatt DL, Steg PG, Miller M, et al. Effects of Icosapent Ethyl
on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol
2019;73(22):2791-2802.
3 Mach F, Baigent C, Catapano A L, et al. 2019 ESC/EAS
Guidelines for the management of dyslipidaemias: lipid modification
to reduce cardiovascular risk: The Task Force for the management of
dyslipidaemias of the European Society of Cardiology and European
Atherosclerosis Society
4 Skulas-Ray AC, Wilson PWF, Harris WS, et al.
Omega-3 Fatty Acids for the Management of Hypertriglyceridemia: A
Science Advisory From the American Heart Association. 2019.
5 American Diabetes Association. Diabetes Care 2019 Jan;
42(Supplement 1): S103-S123. https://doi.org/10.2337/dc19-S010
6 Mach F, Baigent C, Catapano A L, et al. 2019 ESC/EAS
Guidelines for the management of dyslipidaemias: lipid modification
to reduce cardiovascular risk: The Task Force for the management of
dyslipidaemias of the European Society of Cardiology and European
Atherosclerosis Society
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9 American Heart Association. 2018. Disease and Stroke
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costly burden for America projections through 2035.
11 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for
adjunctive dyslipidemia therapy in hypertriglyceridemia management.
J Am Coll Cardiol. 2018;72(3):330-343.
12 Budoff M. Triglycerides and triglyceride-rich lipoproteins in
the causal pathway of cardiovascular disease. Am J Cardiol.
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13 Toth PP, Granowitz C, Hull M, et al. High triglycerides are
associated with increased cardiovascular events, medical costs, and
resource use: A real-world administrative claims analysis of
statin-treated patients with high residual cardiovascular risk. J
Am Heart Assoc. 2018;7(15):e008740.
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atherosclerotic cardiovascular disease - New insights from
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