Latest Research Evaluating VASCEPA® (Icosapent Ethyl) to be Presented at the American College of Cardiology’s 71st Annual Scientific Session
March 21 2022 - 08:30AM
Amarin Corporation plc (NASDAQ:AMRN) today announced a diverse and
full slate of supported and/or funded research on VASCEPA®/VAZKEPA
(icosapent ethyl) to be presented in six posters at the American
College of Cardiology’s 71st Annual Scientific Session in
Washington, DC, April 2-4, 2022.
The posters explore a range of assessments of icosapent ethyl
(the highly purified, prescription form of eicosapentaenoic acid,
or EPA), including a comparison of its impacts when combined with
the most widely used high intensity statins vs. when the statins
alone were used.
“We are always pleased to be a part of this important meeting –
especially when new data and insights on icosapent ethyl are
available to be shared and discussed,” said Karim Mikhail, Amarin’s
president and chief executive officer. “As the evidence base on
icosapent ethyl continues to expand in interesting ways, we are
particularly encouraged by what we’re learning about the potential
role it can play in combination with statins for patients that are
at highest risk.”
Featured Amarin-supported abstracts to be presented at ACC.22
include:
Saturday, April 2, 2022
|
Session 1188 -
Prevention and Health Promotion: Lipids Digital Presentations
eAbstract site; 8:30am Icosapent Ethyl Reduces
Cardiovascular Risk Substantially and Consistently Regardless of
Waist Circumference - presented on behalf of all authors
by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital,
Boston, MA, USASession 1276 -- Vascular Medicine: Pharmacology
2Poster Hall, Hall C; 10:45 – 11:30 AM Eicosapentaenoic
Acid (EPA) Combined with High Intensity Statins Reduce Lipid
Oxidation in Model Membranes - presented on behalf of all
authors by R. Preston Mason, Ph.D., Elucida Research LLC, Beverly,
MA, USA |
Sunday, April 3, 2022
|
Session 1453
Vascular Medicine: Basic and Translational Science 11Poster Hall,
Hall C; 2:45 – 3:30 PMEicosapentaenoic Acid (EPA) Increases
Heme Oxygenase-1 Expression in Macrophages and Endothelial Cells
During Inflammation- presented on behalf of all authors by
Preston Mason, Ph.D.,Elucida Research LLC, Beverly, MA,
USAEicosapentaenoic Acid (EPA) Decreases Angiotensin
Converting Enzyme (ACE) Expression in Vascular and Pulmonary
Endothelium Following Cytokine Challenge- presented on
behalf of all authors by R. Preston Mason, Ph.D.,Elucida Research
LLC, Beverly, MA, USAEicosapentaenoic Acid (EPA) Reduces
Inflammation and Improves Nitric Oxide Bioavailability in Pulmonary
Endothelial Cells Following Exposure to Air Pollution
Particles- presented on behalf of all authors by R.
Preston Mason, Ph.D.,Elucida Research LLC, Beverly, MA, USA |
Monday, April 4, 2022
|
Session 1108
Vascular Medicine Basic/Translational Science: Special Topics
Moderated Poster Theater 5_Hall C; 10:00 – 10:10
AMEicosapentaenoic Acid (EPA) Reduces J774 Macrophage
Activation and Cyclooxygenase (Cox-1) Expression -
presented on behalf of all authors by R. Preston Mason, Ph.D.,
Elucida Research LLC, Beverly, MA, USA |
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.
About VASCEPA® (icosapent ethyl)
CapsulesVASCEPA (icosapent ethyl) capsules are the
first-and-only 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 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 ten million times. VASCEPA is covered by most major
medical insurance plans. In addition to the United States, VASCEPA
is approved and sold in Canada, 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.
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.
Key clinical effects of VASCEPA on major adverse cardiovascular
events are included in the Clinical Studies section of the
prescribing information for VASCEPA as set forth below:
FULL U.S. FDA-APPROVED VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
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 statements regarding any new potential
clinical impact of VASCEPA i, the outcomes or impact of any
specific new or ongoing clinical trials or studies, significance of
any data generated in new or ongoing clinical trials or studies and
general statements 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 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:
Investor Relations Amarin Corporation plc In U.S.: +1 (908)
719-1315 IR@amarincorp.com (investor inquiries)
Media Inquiries: Communications Amarin Corporation plc In U.S.:
+1 (908) 892-2028 PR@amarincorp.com (media inquiries)
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