Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company
focused on improving cardiovascular health, today confirmed that
the American Diabetes Association® (ADA) issued important updates
to the Standards of Medical Care in Diabetes for 2019 (Standards of
Care), including updates related to the results of the REDUCE-IT™
cardiovascular outcomes study. The REDUCE-IT related updates were
informed by newly published research covering REDUCE-IT results and
crafted and approved by the ADA’s Professional Practice Committee,
which is responsible for producing the annual Standards of Care.
The Living Standards of Care are available online at Diabetes
The Standards of Care update references the
drug, icosapent ethyl, studied in REDUCE-IT, which Amarin markets
under the brand name, Vascepa® (icosapent ethyl) capsules. Vascepa
has been approved for use by the United States Food and Drug
Administration (FDA) as an adjunct to diet to reduce triglyceride
levels in adult patients with severe (≥500 mg/dL)
hypertriglyceridemia. Amarin has commenced transmission of data to
the FDA to support the submission of a supplemental new drug
application (sNDA) seeking an expansion of the Vascepa FDA label
based on the landmark REDUCE-IT results. Accordingly, FDA has not
reviewed and opined on a sNDA related to REDUCE-IT. ADA does not
provide endorsements or any form of certification for brand name
commercial products as a general policy of the organization.
Accordingly, the inclusion of icosapent ethyl in ADA’s Standards of
Care should not be understood as an endorsement or approval by ADA
Based on the results of REDUCE-IT™2, 3 in both
primary and secondary prevention populations, the Living Standards
of Care now include the recommendation that icosapent
“…be considered for patients with diabetes and
atherosclerotic cardiovascular disease (ASCVD) or other cardiac
risk factors on a statin with controlled low-density cholesterol
(LDL-C), but with elevated triglycerides (135-499) to reduce
The ADA added that this updated finding was:
“…based on the outcome of Reduction of
Cardiovascular Events with Icosapent Ethyl–Intervention Trial
(REDUCE-IT), which determined the addition of icosapent ethyl to
statin therapy for patients with high triglyceride levels reduced
The ADA standards also reiterate that:
“It should be noted that data are lacking with
other omega-3 fatty acids, and results of the REDUCE-IT trial
should not be extrapolated to other products.”
Cardiovascular disease is the leading cause of
morbidity and mortality for individuals with diabetes, and
cardiovascular disease is the cause of one in three deaths in the
U.S. The ADA added that:
“Recently published research indicated an urgent
need to update the 2019 Standards of Care to ensure optimal
treatment recommendations for people with cardiovascular disease
The findings were made with a level “A” grade of
scientific evidence4, which under ADA standards, reflects that
REDUCE-IT was considered to be a large well-designed clinical
trial. Generally, according to ADA, A-level recommendations have
the best chance of improving outcomes when applied to the
population to which they are appropriate.
“As we have commenced transmission of data to
the FDA for the submission of our sNDA seeking an expansion of the
Vascepa label based on the landmark REDUCE-IT results, we are
pleased by ADA’s acknowledgement of the importance of the REDUCE-IT
results in its 2019 update of the Standards of Care,” said Craig B.
Granowitz, M.D., Ph.D., senior vice president and chief medical
officer of Amarin. “The medical community will also hopefully
take note of recent research reporting the prevalence of, and
increased costs associated with, diabetes mellitus and high
triglyceride levels despite statin therapy5.”
Amarin acknowledges the rigor with which the
Standards of Care are reviewed by ADA’s Professional Practice
Committee. The committee is comprised of a multidisciplinary team
of 14 leading U.S. experts in the field of diabetes care. This
includes physicians, diabetes educators, registered dietitians and
others whose experience includes adult and pediatric endocrinology,
epidemiology, public health, lipid research, hypertension,
preconception planning and pregnancy care. For the 2019 Standards
of Care, Amarin has been informed that two designated
representatives from the American College of Cardiology (ACC)
reviewed the new updates and provided feedback on behalf of the ACC
consistent with the final findings.
The complete, annotated Standards of Care, which
includes the recent updated findings, can be accessed online on
Diabetes Care. The Abridged Standards of Medical Care in Diabetes
have also been updated and can be accessed online on Clinical
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
REDUCE-IT3, 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.
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.6,
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
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. 9, 10, 11, 12
About Vascepa (icosapent ethyl)
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.
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)
- The effect of Vascepa on the risk
for pancreatitis and cardiovascular mortality and morbidity in
patients with severe hypertriglyceridemia has not been
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
- 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
- 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 Medicine3
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
- 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
Vascepa has been approved for use by the United
States Food and Drug Administration (FDA) as an adjunct to diet to
reduce triglyceride levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia. FDA has not reviewed and opined on a
supplemental new drug application related to REDUCE-IT. FDA has not
reviewed the information herein or determined whether to approve
Vascepa for use to reduce the risk of MACE. Nothing in this press
release should be construed as promoting the use of Vascepa in any
indication that has not been approved by the FDA.
Important Cautionary Information About
Further REDUCE-IT data assessment and data
release could yield additional useful information to inform greater
understanding of the trial outcome. Further detailed data
assessment by Amarin and regulatory authorities will
continue and take several months to complete and record. The final
evaluation of the totality of the efficacy and safety data from
REDUCE-IT may include some or all of the following, as well as
other considerations: new information 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; consideration
of REDUCE-IT results in the context of other clinical studies.
Recurrent event analyses for the total primary
endpoint events and for the total key secondary endpoint in
REDUCE-IT as published in the Journal of the American College of
Cardiology were conducted using a series of statistical models.
These analyses were tertiary or exploratory endpoints; most of the
models used were prespecified and one was post hoc. Each recurrent
event statistical model has inherent strengths and weaknesses, with
no single model considered definitive or outperforming the other
models, and this is an evolving field of science. Nonetheless,
results from the total primary and total key secondary endpoint
events analyses are consistent across the various recurrent event
statistical models and are also consistent with the original
primary and secondary endpoint results. Together, the REDUCE-IT
recurrent event analyses and the original primary and key secondary
endpoint analyses support the robustness of the clinical benefit of
Vascepa therapy in reducing cardiovascular risk.
This press release contains forward-looking
statements, including expectations regarding FDA submission and
applicability and reliability of REDUCE-IT results. These
forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. In addition, Amarin's
ability to effectively commercialize Vascepa will depend in part on
its ability to continue to effectively finance its business,
efforts of third parties, its ability to gain regulatory approvals,
create market demand for Vascepa through education, marketing and
sales activities, to achieve market acceptance of Vascepa, to
receive adequate levels of reimbursement from third-party payers,
to develop and maintain a consistent source of commercial supply at
a competitive price, to comply with legal and regulatory
requirements in connection with the sale and promotion of Vascepa
and to maintain patent protection for Vascepa. 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 approvals; the risk that sales may not meet
expectations and related cost may increase beyond expectations; the
risk that patents may not be upheld in patent litigation and
applications may not result in issued patents sufficient to protect
the Vascepa franchise. 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 annual report on
Form 10-K. 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
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.
1 American Diabetes Association. 10.
Cardiovascular Disease and Risk Management: Standards of Medical
Care in Diabetes—2019.
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. epub ahead of print.
3 Bhatt DL, Steg PG, Miller M, et al.
Cardiovascular Risk Reduction with Icosapent Ethyl for
Hypertriglyceridemia. N Engl J Med 2019;380:11-22.
4 American Diabetes Association.
Introduction; Standards of Medical Care in Diabetes-2019.
5 Nichols G, Philip S, Granowitz CB, et al.
Increased cardiovascular risk in patients with diabetes,
statin-controlled LDL cholesterol, and residual
hypertriglyceridemia [abstract]. Diabetes. 2018;67(suppl 1):1485P.
6 American Heart Association. 2018. Disease
and Stroke Statistics-2018 Update.
7 American Heart Association. 2017.
Cardiovascular disease: A costly burden for America projections
8 Ganda OP, Bhatt DL, Mason RP, et al.
Unmet need for adjunctive dyslipidemia therapy in
hypertriglyceridemia management. J Am Coll Cardiol.
9 Budoff M. Triglycerides and
triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol. 2016;118:138-145.
10 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.
11 Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
12 Nordestgaard BG, Varbo A. Triglycerides
and cardiovascular disease. Lancet. 2014;384:626–635.
Amarin Contact Information
Investor Relations:Elisabeth SchwartzInvestor Relations and
Corporate Communications Amarin Corporation plc In U.S.: +1
(908) 719-1315 firstname.lastname@example.org (investor
inquiries) PR@amarincorp.com (media inquiries)
Lee M. Stern Trout Group In U.S.: +1 (646)
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