Amarin Corporation plc (NASDAQ:AMRN) today announced new supported
and/or funded research from the landmark REDUCE-IT cardiovascular
outcomes trial on the effects of VASCEPA®/VAZKEPA® (icosapent
ethyl) in a specific patient subgroups at increased risk of a
cardiovascular (CV) event has been accepted for presentation at the
American Heart Association (AHA) Scientific Sessions 2023, taking
place November 11 – 13, 2023 in Philadelphia, PA.
The accepted abstracts include a presentation on the reduction
in first and total CV events following treatment with
VASCEPA/VAZKEPA in a unique, high-risk patient subgroup with a
history of Metabolic Syndrome at baseline, but without diabetes.
This subgroup was almost exclusively comprised of patients with
established cardiovascular disease. In addition, data from
mechanistic analyses will be presented providing additional
insights into Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid
(DHA) and their differential effects in model lipid membranes as
well as the effects of EPA on oxidation of Lp(a) enriched plasma.
Lastly, an abstract describing the demographic/clinical
characteristics of US patients taking icosapent ethyl, focusing on
those with diabetes, will also be presented. These and other new
findings will be presented by a variety of international academic
collaborators based on research or analyses supported by
Amarin.
Nabil Abadir, MB. CH.B., SVP, Chief Medical Officer, and Head of
Global Medical Affairs at Amarin, commented on the data being
presented at the meeting, stating, "The data being presented at
Scientific Sessions continue to further validate the overall
results of the REDUCE-IT trial and the added value of
VASCEPA/VAZKEPA for patients. With these data we now have more
insights into patients with a history of Metabolic Syndrome at
baseline, including those secondary prevention patients with
established cardiovascular disease, a patient group particularly at
high-risk of having another cardiovascular event. Additionally, we
are pleased to support data being featured at the meeting
highlighting the characteristics of patients with diabetes who were
put on IPE in a real world setting as well as data that continue to
illuminate the mechanism of action underlying the icosapent ethyl
molecule."
“This latest research reaffirms Amarin's commitment to advancing
cardiovascular care and highlights the potential benefits of
VASCEPA®/VAZKEPA® in improving the health and well-being of
patients at increased risk of cardiovascular events,” concluded
Abadir.
Featured Amarin-supported abstracts to be
presented at AHA Scientific Sessions 2023 include:
Oral Presentation
- Effectiveness of Icosapent
Ethyl on First and Total Cardiovascular Events in the Metabolic
Syndrome: REDUCE-IT MetSyn
Michael Miller, Deepak L. Bhatt, Eliot A. Brinton, Terry A
Jacobson et al...
– Available November 12th, 9-9:10 am
Poster Presentations
- Cross-Sectional Analysis of
Demographic and Clinical Characteristics of Patients
Using Icosapent Ethyl, With a Focus on Patients With
Diabetes
Om P Ganda, Peter P Toth, Handrean Soran, et al...
- Available November 12th, 11:30-12:45 pm
- Zone 3, Science and Technology Hall, Level 2
- Eicosapentaenoic Acid
Inhibits Lipoprotein(a) With Higher Rates of Oxidation Compared to
Non-Modified Low-Density Lipoprotein In Vitro
Preston Mason, Samuel CR Sherratt, Peter Libby, et al…
– Available November 11th, 11:30-12:45 pm
- Zone 1, Science and Technology Hall, Level 2
- Eicosapentaenoic Acid (EPA)
and Docosahexaenoic Acid (DHA) have Competing Effects on Membrane
Lipid Dynamics due to Differences in StructurePreston
Mason, Samuel C.R. Sherratt, Sandeep Shrivastava, et
al...
– Available November 11th, 11:30-12:45 pm
- Zone 1, Science and Technology Hall, Level 2
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) 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 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, Germany,
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.
FULL U.S. FDA-APPROVED VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
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 role concerning appropriate patients suffering from
cardiovascular disease (CVD) and potential population health
impact, 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 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 ZwickAmarin Corporation plc In U.S.:
+1 (908) 719-1315 IR@amarincorp.com (investor inquiries)
Media Inquiries: Mark MarmurAmarin Corporation plc In U.S.: +1
(908) 892-2028 PR@amarincorp.com (media inquiries)
Amarin (NASDAQ:AMRN)
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