Amarin Corporation plc (NASDAQ: AMRN), a pharmaceutical company
focused on improving cardiovascular health, today announced that
the National Lipid Association (NLA) has issued a position
statement recognizing the cardiovascular risk-lowering effects of
icosapent ethyl based on the landmark REDUCE-IT™ cardiovascular
outcomes study.
The NLA is recommending icosapent ethyl for atherosclerotic
cardiovascular disease (ASCVD) risk reduction in high and
very-high-risk patients, 45 years of age or older with clinical
ASCVD, or 50 years of age or older with type 2 diabetes requiring
medication and with ≥ 1 additional risk factor, and fasting
triglycerides of 135-499 mg/dL on maximally tolerated statin, with
or without ezetimibe. The NLA recommendation was issued as a Class
I, Level B-R (STRONG) recommendation, its highest designation, for
icosapent ethyl. The NLA is a leading professional society
dedicated to enhancing the practice of lipid management in clinical
medicine.
Icosapent ethyl – which has been extensively studied in a series
of clinical trials, including the REDUCE-IT cardiovascular outcomes
study1,2– was developed by Amarin and is exclusively marketed by
Amarin and its commercial partners in capsule form under the brand
name Vascepa®. In the United States, Vascepa is 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 a
label expansion based on the landmark REDUCE-IT results showing
reduction of cardiovascular events in high-risk patients. The
Prescription Drug User Fee Act (PDUFA) target action date set by
the FDA to act on the sNDA is December 28, 2019. Assuming FDA
approval, Vascepa is positioned to become the first drug indicated
to reduce residual cardiovascular risk in statin-managed patients
with elevated triglycerides (135 mg/dL or greater) and other risk
factors for cardiovascular disease. The approval of such label
expansion and the wording of the indication statement is under
regulatory review. Based on REDUCE-IT, Vascepa use was determined
to be cost-effective by an independent third-party organization in
the United States that assesses the economic value of drugs.
The NLA does not provide endorsements or any form of
certification for brand name commercial products. Accordingly, the
NLA position on icosapent ethyl should not be understood as an
endorsement or approval by the NLA of Vascepa.
Antonio M. Gotto, Jr., M.D., D.Phil., FNLA, president of the
National Lipid Association, stated: “The NLA has a long history in
the atherosclerotic cardiovascular disease risk and triglyceride
space. REDUCE-IT is an important contribution to our understanding
of the use of omega-3 fatty acids in ASCVD risk reduction. The NLA
has reviewed the existing data between ASCVD, hypertriglyceridemic
patients, and high dose omega-3 fatty acids and recommends the use
of icosapent ethyl in appropriate high and very-high-risk
patients.”
Craig B. Granowitz, M.D., Ph.D., senior vice president and chief
medical officer of Amarin, said: “The NLA is uniquely focused on
improving patient care by reducing atherosclerotic cardiovascular
disease. To have this highly credible organization recognize the
quality of the REDUCE-IT data and the potential of icosapent ethyl
as a new treatment option for potentially millions of people on
statins with elevated triglycerides who are at risk of
cardiovascular events is tremendous. Icosapent ethyl is the only
non-cholesterol lowering agent with demonstrated cardiovascular
risk reduction outcomes results recommended for use by NLA.”
In issuing its new position statement, the National Lipid
Association joins the European Society of Cardiology, European
Atherosclerosis Society, American Heart Association, and American
Diabetes Association in recognizing the use of icosapent ethyl to
reduce cardiovascular risks in appropriate patients on statins with
elevated triglycerides.3,4,5 Together, these organizations
represent the world’s leading medical bodies in management of
cardiology and endocrinology.
In the United States, approximately 15 million people have
triglycerides ≥ 135 mg/dL and other cardiovascular risk factors,
despite statin treatment.6 Cardiovascular risks for these patients
include heart attack, stroke or death.
The “NLA Position on the Use of Icosapent Ethyl in High and
Very-High-Risk Patients” was crafted and approved by the NLA’s
Board of Directors, comprised of leading experts who specialize in
clinical lipidology. The position statement will be submitted for
publication in the NLA’s Journal of Clinical Lipidology.
About Amarin Amarin 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™ Study REDUCE-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 Disease Worldwide,
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.7,8
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.9
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.10,11,12,13
About Vascepa® (icosapent ethyl) Capsules
Vascepa (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 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 Statements This 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 Amarin
Investors 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 Information Investor
Inquiries: Elisabeth Schwartz Investor Relations Amarin
Corporation plc In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. Stern Solebury Trout In U.S.: +1 (646) 378-2992
lstern@soleburytrout.com
Media Inquiries: Gwen Fisher Corporate
Communications Amarin Corporation plc In U.S.: +1 (908) 325-0735
pr@amarincorp.com
References
_____________________________
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Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J
Med 2019;380:11-22.2 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):2791-2802.3Mach 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.4Skulas-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 Philip S, Fan W,
Granowitz C, Toth P, Wong N. Prevalence of US adults with
triglycerides ≥135 mg/dL: NHANES 2007-2014. J Clin Lipidol. 2019;
epub ahead of print.
https://els-jbs-prod-cdn.literatumonline.com/pb/assets/raw/Health%20Advance/journals/jacl/jacl_abstracts-1558015686367.pdf.7
American Heart Association. 2018. Disease and Stroke
Statistics-2018 Update.8 American Heart Association. 2017.
Cardiovascular disease: A costly burden for America projections
through 2035.9 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for
adjunctive dyslipidemia therapy in hypertriglyceridemia management.
J Am Coll Cardiol. 2018;72(3):330-343.10 Budoff M. Triglycerides
and triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol. 2016;118:138-145.11 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):e008740.12 Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.13 Nordestgaard BG, Varbo A. Triglycerides and
cardiovascular disease. Lancet. 2014;384:626–635.
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