Amarin Corporation plc (NASDAQ:AMRN) today announced results from
new REDUCE-IT analyses showing that among statin-treated patients
in a prespecified subgroup with history of Metabolic Syndrome, but
without diabetes at baseline, the addition of VASCEPA/VAZKEPA
(icosapent ethyl) significantly reduced the risk of first and total
cardiovascular events. This subgroup was almost exclusively
comprised of patients with established cardiovascular disease. The
results were presented today at the American Heart Association
(AHA) Scientific Sessions 2023, taking place November 11 – 13, 2023
in Philadelphia, PA and simultaneously published in the European
Heart Journal Open.
More than 1 out of every 3 adult Americans have Metabolic
Syndrome, a cluster of 3 or more of 5 risk factors: 1) waist
circumference ≥40 inches [102 cm] in men and ≥35 inches [88 cm] in
women, 2) blood pressure ≥130/85 mmHg, 3) glucose ≥100 mg/dL, 4)
triglycerides ≥150 mg/dL, and 5) HDL-C <40 mg/dL in men and
<50 mg/dL in women.
Among patients with Metabolic Syndrome but without diabetes at
baseline (n=2866), those who were allocated to icosapent ethyl
(IPE) treatment with a median follow-up time of 4.9 years
experienced a 29% relative risk reduction for the primary composite
endpoint, defined as cardiovascular death, nonfatal myocardial
infarction, nonfatal stroke, coronary revascularization, or
unstable angina resulting in hospitalization (P <0.0001)
(Absolute Risk Reduction [ARR]=5.9%; number needed to treat
[NNT]=17) and a 41% reduction in total (first plus subsequent)
events (P <0.0001) compared with placebo. The risk for the key
secondary composite endpoint, defined as cardiovascular death,
nonfatal myocardial infarction, or nonfatal stroke was reduced by
20% (P=0.05) and there was a 27% reduction in fatal/nonfatal
myocardial infarction (P=0.03), 47% reduction in urgent/emergent
revascularization (P <0.0001) and 58% reduction in
hospitalization for unstable angina (P <0.0001).
Non-statistically significant reductions were observed in cardiac
arrest (44%) and sudden cardiac death (34%).
The large relative and absolute risk reductions observed
supports IPE as an important therapeutic option for patients with
metabolic syndrome at high cardiovascular risk, despite lacking
robust effects on any metabolic syndrome component.
“These subgroup findings provide us with valuable insight into
the role icosapent ethyl may play in helping reduce the risk of
cardiovascular events in patients with Metabolic Syndrome, but
without concomitant diabetes, including those secondary prevention
patients with established cardiovascular disease, a patient group
particularly at high-risk of having another cardiovascular event,”
said Michael Miller, M.D., cardiologist and Chief of Medicine,
Corporal Michael J Crescenz Veterans Affairs Medical Center and
Professor of Medicine, Hospital of the University of Pennsylvania
in Philadelphia. “This is an area of growing concern for the
medical community and for patients globally, given the steady rise
in the number of patients with Metabolic Syndrome across the U.S.
and around the world.”
Commenting on the findings, Amarin’s Chief Medical Officer Nabil
Abadir said, “These data continue to reinforce the clinical value
of IPE and expand the growing list of benefits attributable to the
molecule, including secondary prevention patients such as those
with prior myocardial infarction, percutaneous coronary
intervention or coronary bypass grafting, chronic kidney disease,
heart failure, and history of cigarette smoking.”
Limitations of these analyses, some of which are exploratory in
nature, include the relatively small number of events in certain
subgroups or for certain endpoints, such as cardiac arrest and
sudden cardiac death. In addition, variation in subjective measures
(e.g., waist circumference) may have affected classification of
metabolic syndrome.
About Metabolic Syndrome
Metabolic Syndrome is a cluster of conditions that increase the
risk of heart disease, stroke and Type 2 diabetes mellitus (T2DM).
Metabolic Syndrome is defined as the presence of any three of the
following five risk factors: increased blood pressure, high blood
sugar, excess body fat around the waist, low HDL cholesterol,
or elevated/high triglyceride levels.1 Metabolic Syndrome is
increasingly common,1 and more than 1 out of 3 people in
the United States have it. Metabolic Syndrome is not only
associated with a two-fold increased risk of adverse cardiovascular
disease (CVD) outcomes (e.g., myocardial infarction, stroke and CV
mortality), even in the absence of T2DM, but in recent years has
also been linked to a variety of pathogenic phenotypes including
heart failure and renal insufficiency.2,3,4
About Cardiovascular Risk
Cardiovascular 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,5 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%.6 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.7,8,9
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.10 The primary results of
REDUCE-IT were published in The New England Journal of Medicine in
November 201811. The total events 12 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 (icosapent ethyl) capsules are the first prescription
treatment approved by the U.S. Food and Drug Administration (FDA)
comprised solely of the active ingredient, icosapent ethyl (IPE), a
unique form of eicosapentaenoic acid. VASCEPA was launched in the
United States in January 2020 as the first drug approved by the
U.S. FDA for treatment of the studied high-risk patients with
persistent cardiovascular risk despite being on 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 more than twenty million times. VASCEPA
is covered by most major medical insurance plans. In addition to
the United States, VASCEPA is approved and sold in Canada, China,
Lebanon 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 (applying to
England, Scotland and Wales). VAZKEPA (icosapent ethyl) is
currently approved and sold in Europe in Sweden, Denmark, Finland,
Austria, the UK, Spain and the Netherlands.
Indications and Limitation of Use (in
the United States)
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.
About Amarin
Amarin is an innovative pharmaceutical company leading a new
paradigm in cardiovascular disease management. From our foundation
in scientific research 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, Zug in Switzerland, and other countries in Europe as
well as commercial partners and suppliers around the world. We are
committed to increasing the scientific understanding of the
cardiovascular risk that persists beyond traditional therapies and
advancing the treatment of that risk.
Forward-Looking Statements This 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 potential role in helping reduce the risk of cardiovascular
events in patients with Metabolic Syndrome, but without concomitant
diabetes, as well as general beliefs about the safety and
effectiveness of VASCEPA/VAZKEPA. 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 2022. 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 and 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:
Jordan Zwick
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
IR@amarincorp.com (investor inquiries)
Media Inquiries:
Mark Marmur
Amarin Corporation plc
In U.S.: +1 (908) 892-2028
PR@amarincorp.com (media inquiries)
1 Mayo Clinic Metabolic Syndrome – Overview:
https://www.mayoclinic.org/diseases-conditions/metabolic-syndrome/symptoms-causes/syc-20351916 2
Mottillo S, Filion KB, Genest J, Joseph L, Pilote L, Poirier P et
al. The metabolic syndrome and cardiovascular risk a systematic
review and meta-analysis. J Am Coll Cardiol 2020;56:1113–1132.3
Burger PM, Koudstaal S, Dorresteijn JAN, Savarese G, van der Meer
MG, de Borst GJ, Mosterd A, Visseren FLJ; UCC-SMART study group.
Metabolic syndrome and risk of incident heart failure in
non-diabetic patients with established cardiovascular disease.Int J
Cardiol. 2023;379:66-75.4 Li X, Liang Q, Zhong J, Gan L, Zuo L. The
Effect of Metabolic Syndrome and Its Individual Components on Renal
Function: A Meta-Analysis. J Clin Med. 2023;12:1614.5 American
Heart Association. Heart Disease and Stroke Statistics—2020 Update:
A Report From the American Heart Association. Circulation.
2020;141:e139-e5966 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need
for adjunctive dyslipidemia therapy in hypertriglyceridemia
management. J Am Coll Cardiol. 2018;72(3):330-343.7 Budoff M.
Triglycerides and triglyceride-rich lipoproteins in the causal
pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.8
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):e008740.9 Nordestgaard BG.
Triglyceride-rich lipoproteins and atherosclerotic cardiovascular
disease - New insights from epidemiology, genetics, and biology.
Circ Res. 2016;118:547-563.10 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;40:138-148.11 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;380:11-2212 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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