Amarin Corporation plc (NASDAQ:AMRN) today announced that new
REDUCE-IT data show that VASCEPA/VAZKEPA (icosapent ethyl)
significantly reduced ST-segment elevation myocardial infarction
(STEMI), non-ST segment elevated myocardial infarction (NSTEMI),
and other MI subtypes in patients with established cardiovascular
disease (CVD) or diabetes with risk factors.
The REDUCE-IT data presented today show STEMI was significantly
reduced by 40% following treatment with icosapent ethyl (IPE)
compared to placebo. IPE also significantly reduced NSTEMI by 27%.
These data were presented today during a Late-Breaking Science
Session at the European Society of Cardiology (ESC) Congress 2022
in Barcelona, Spain.
“This analysis of REDUCE-IT clearly shows that IPE 4 g/day as an
adjunct to statin therapy in high-risk patients with residual
hypertriglyceridemia provides a large and significant reduction in
heart attacks,” said 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 of the REDUCE-IT trial. “Importantly,
these new data show a significant reduction in the most important
type of heart attack known as STEMI, as well as other MI
subtypes.”
The REDUCE-IT study randomized 8,179 adult statin-treated
patients with elevated triglycerides and either established CV
disease or diabetes plus risk factors to IPE or placebo; median
follow-up was 4.9 years. IPE treatment reduced the primary
composite endpoint (CV death, nonfatal myocardial infarction [MI],
nonfatal stroke, coronary revascularization, or hospitalization for
unstable angina) and key secondary composite endpoint (CV death,
nonfatal MI, or nonfatal stroke) endpoints 25% and 26%,
respectively. Prespecified and post hoc analyses examined MI
subtypes, which were independently adjudicated by a blinded
Clinical Endpoint Committee.
In time to first event analyses, MI was significantly reduced
with IPE treatment (HR=0.69; 95% CI 0.58, 0.81; P<0.0001) with a
number needed to treat (NNT) of 39. IPE significantly reduced STEMI
(HR=0.60; 95% CI 0.44, 0.81; P=0.0008) and NSTEMI (HR=0.73; 95% CI
0.60, 0.89; P=0.001). There were clinically important and
statistically significant reductions in MI subtypes, including MI
leading to cardiac arrest (HR=0.49; 95% CI 0.28, 0.87; P=0.01) and
resuscitated MI (HR=0.34; 95% CI 0.15, 0.76; P=0.006). IPE also
significantly reduced the overall burden of total (first and
subsequent) STEMI (rate ratio [RR]=0.59; 95% CI 0.43, 0.80;
P=0.0006) and total NSTEMI (RR=0.72; 95% CI 0.58, 0.88; P=0.002)
versus placebo.
All analyses highlighted above were funded by Amarin. Dr. Bhatt
received research funding paid to Brigham and Women’s Hospital from
Amarin for his role as the Chair of REDUCE-IT.
About AmarinAmarin is an innovative
pharmaceutical company leading a new paradigm in cardiovascular
disease management. From our scientific research foundation to our
focus on clinical trials, and now our commercial expansion, we are
evolving and growing rapidly. Amarin has offices in Bridgewater,
New Jersey in the United States, Dublin in Ireland, and Zug in
Switzerland as well as commercial partners and suppliers around the
world. We are committed to rethinking cardiovascular risk through
the advancement of scientific understanding of the impact on
society of significant residual risk that exists beyond traditional
therapies, such as statins for cholesterol management.
About Cardiovascular RiskCardiovascular disease
is the number one cause of death in the world. In the United States
alone, cardiovascular disease results in 859,000 deaths per
year.1 And the number of deaths in the United States
attributed to cardiovascular disease continues to rise. In
addition, in the United States there are 605,000 new and 200,000
recurrent heart attacks per year (approximately 1 every 40
seconds). Stroke rates are 795,000 per year (approximately 1 every
40 seconds), accounting for 1 of every 19 U.S. deaths. In
aggregate, in the United States alone, there are more than 2.4
million major adverse cardiovascular events per year from
cardiovascular disease or, on average, 1 every 13 seconds.
Controlling bad cholesterol, also known as LDL-C, is one way to
reduce a patient’s risk for cardiovascular events, such as heart
attack, stroke or death. However, even with the achievement of
target LDL-C levels, millions of patients still have significant
and persistent risk of cardiovascular events, especially those
patients with elevated triglycerides. Statin therapy has been shown
to control LDL-C, thereby reducing the risk of cardiovascular
events by 25-35%.2 Significant cardiovascular risk remains
after statin therapy. People with elevated triglycerides have 35%
more cardiovascular events compared to people with normal (in
range) triglycerides taking statins.3,4,5
About REDUCE-IT®REDUCE-IT was a global
cardiovascular outcomes study designed to evaluate the effect of
VASCEPA in adult patients with LDL-C controlled to between 41-100
mg/dL (median baseline 75 mg/dL) by statin therapy and various
cardiovascular risk factors including persistent elevated
triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and
either established cardiovascular disease (secondary prevention
cohort) or diabetes mellitus and at least one other cardiovascular
risk factor (primary prevention cohort).
REDUCE-IT, conducted over seven years and completed in 2018,
followed 8,179 patients at over 400 clinical sites in 11 countries
with the largest number of sites located within the United States.
REDUCE-IT was conducted based on a special protocol assessment
agreement with FDA. The design of the REDUCE-IT study was published
in March 2017 in Clinical Cardiology.6 The primary
results of REDUCE-IT were published in The New England Journal
of Medicine in November 2018.7 The total events results
of REDUCE-IT were published in the Journal of the American
College of Cardiology in March 2019.8 These and other
publications can be found in the R&D section on the company’s
website at www.amarincorp.com.
About
VASCEPA®/VAZKEPA®
(icosapent ethyl) Capsules
VASCEPA capsules are the first prescription
treatment approved by the U.S. Food and Drug Administration (FDA)
comprised solely of the active ingredient, icosapent ethyl, a
unique form of eicosapentaenoic acid. VASCEPA was launched in the
United States in January 2020 as the first and only drug approved
by the U.S. FDA for treatment of the studied high-risk patients
with persistent cardiovascular risk after statin therapy. VASCEPA
was initially launched in the United States in 2013 based on the
drug’s initial FDA approved indication for use as an adjunct
therapy to diet to reduce triglyceride levels in adult patients
with severe (≥500 mg/dL) hypertriglyceridemia. Since launch,
VASCEPA has been prescribed over 18 million times. VASCEPA is
covered by most major medical insurance plans. In addition to the
United States, icosapent ethyl is approved and sold in Canada,
Lebanon, Germany and the United Arab Emirates. In Europe, in March
2021 marketing authorization was granted to icosapent ethyl in the
European Union for the reduction of risk of cardiovascular events
in patients at high cardiovascular risk, under the brand name
VAZKEPA. In April 2021 marketing authorization for VAZKEPA
(icosapent ethyl) was granted in Great Britain. The Great Britain
Marketing Authorization for VAZKEPA applies to England, Scotland
and Wales.
United StatesIndications and Limitation
of Use
VASCEPA is indicated:
- As an adjunct to maximally tolerated statin therapy to reduce
the risk of myocardial infarction, stroke, coronary
revascularization and unstable angina requiring hospitalization in
adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL)
and
- established cardiovascular disease or
- diabetes mellitus and two or more additional risk factors for
cardiovascular disease.
- As an adjunct to diet to reduce TG levels in adult patients
with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis in patients
with severe hypertriglyceridemia has not been determined.
Important Safety Information
- VASCEPA is contraindicated in patients with known
hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of
its components.
- VASCEPA was associated with an increased risk (3% vs 2%) of
atrial fibrillation or atrial flutter requiring hospitalization in
a double-blind, placebo-controlled trial. The incidence of atrial
fibrillation was greater in patients with a previous history of
atrial fibrillation or atrial flutter.
- It is not known whether patients with allergies to fish and/or
shellfish are at an increased risk of an allergic reaction to
VASCEPA. Patients with such allergies should discontinue VASCEPA if
any reactions occur.
- VASCEPA was associated with an increased risk (12% vs 10%) of
bleeding in a double-blind, placebo-controlled trial. The incidence
of bleeding was greater in patients receiving concomitant
antithrombotic medications, such as aspirin, clopidogrel or
warfarin.
- Common adverse reactions in the cardiovascular outcomes trial
(incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal
pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs
4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
- Common adverse reactions in the hypertriglyceridemia trials
(incidence >1% more frequent than placebo): arthralgia (2% vs
1%) and oropharyngeal pain (1% vs 0.3%).
- Adverse events may be reported by calling 1-855-VASCEPA or the
FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and concomitant anticoagulants
and/or anti-platelet agents should be monitored for bleeding.
FULL U.S. FDA-APPROVED
VASCEPA PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Europe
For further information about the Summary of Product
Characteristics (SmPC) for VAZKEPA® in Europe, please click
here.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
Forward-Looking StatementsThis press release
contains forward-looking statements which are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, including beliefs about the potential for VASCEPA
(marketed as VAZKEPA in Europe); beliefs about icosapent ethyl
(IPE)’s role concerning patients suffering from cardiovascular
disease (CVD) and impacts on the risk of heart attack, stroke or
other fatal or non-fatal cardiovascular events for patients who
suffered a prior heart attack, as well as general beliefs about the
safety and effectiveness of VASCEPA. These forward-looking
statements are not promises or guarantees and involve substantial
risks and uncertainties. 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 Amarin’s annual report on Form
10-K for the full year ended 2021. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date they
are made. Amarin undertakes no obligation to update or revise the
information contained in its forward-looking statements, whether as
a result of new information, future events or circumstances or
otherwise. Amarin’s forward-looking statements do not reflect the
potential impact of significant transactions the company may enter
into, such as mergers, acquisitions, dispositions, joint ventures
or any material agreements that Amarin may enter into, amend or
terminate. Availability of Other Information About Amarin
communicates with its investors and the public using the company
website (www.amarincorp.com) and the investor relations website
(investor.amarincorp.com), including but not limited to investor
presentations, 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.
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:Investor RelationsAmarin Corporation plcIn U.S.:
+1 (908) 719-1315IR@amarincorp.com
Media Inquiries:CommunicationsAmarin
Corporation plcIn U.S.: +1 (908) 892-2028PR@amarincorp.com
AMARIN, REDUCE-IT, VASCEPA and VAZKEPA are
trademarks of Amarin Pharmaceuticals Ireland Limited. VAZKEPA is a
registered trademark in Europe and other countries and regions and
is pending registration in the United States.
1 American Heart Association. Heart Disease and Stroke
Statistics—2020 Update: A Report From the American Heart
Association. Circulation. 2020;141:e139-e596.2 Ganda OP,
Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia
therapy in hypertriglyceridemia management. J Am
Coll Cardiol. 2018;72(3):330-343.3 Budoff M.
Triglycerides and triglyceride-rich lipoproteins in the causal
pathway of cardiovascular disease. Am J Cardiol.
2016;118:138-145.4 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):e008740.5 Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.6 Bhatt DL, Steg PG, Brinton E, et al., on
behalf of the REDUCE-IT Investigators. Rationale and Design of
REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent
Ethyl–Intervention Trial. Clin Cardiol.
2017;40:138-148.7 Bhatt DL, Steg PG, Miller M, et al., on
behalf of the REDUCE-IT Investigators. Cardiovascular Risk
Reduction with Icosapent Ethyl for
Hypertriglyceridemia. N Engl J Med.
2019;380:11-22.8 Bhatt DL, Steg PG, Miller M, et al., on
behalf of the REDUCE-IT investigators. Effects of Icosapent Ethyl
on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol.
2019;73:2791-2802.
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