Amarin Corporation plc (NASDAQ:AMRN) today announced an exploratory
post hoc sub-analysis of REDUCE-IT serum samples that found
statin-treated patients allocated to icosapent ethyl (IPE) had
limited differences in certain lipid and inflammatory biomarkers
compared with statin-treated patients allocated to mineral oil
placebo. These findings are consistent with prior reported data and
support previous analyses that demonstrated the majority of benefit
from IPE was from achieved eicosapentaenoic acid (EPA) levels in
REDUCE-IT. This sub-analysis was published online today in the
journal Circulation.
In the landmark REDUCE-IT cardiovascular outcomes study, IPE
achieved 25 percent relative risk reduction of major adverse
cardiovascular events (MACE, 5-point composite endpoint:
cardiovascular death, non-fatal heart attack, non-fatal stroke,
coronary revascularization, or unstable angina). This also included
relative risk reductions of 31 percent, 28 percent and 20 percent
in heart attacks, strokes and cardiovascular deaths, respectively.
As previously presented, the only marker that seems to have strong
association with reductions in MACE from the REDUCE-IT study is
serum EPA levels; these data were previously presented at the
American College of Cardiology Scientific Sessions in 2020.i
“Regardless of biomarker pathway, effects were small on an
absolute scale for both icosapent ethyl and for placebo, and
changes in values were mostly below the limits of quantification in
this exploratory sub-analysis,” said Deepak L. Bhatt, M.D., M.P.H.,
Executive Director of Interventional Cardiovascular Programs at
Brigham and Women’s Hospital and Professor of Medicine at Harvard
Medical School, principal investigator of REDUCE-IT and co-author
of the biomarker sub-analysis. “While the mechanisms of action
contributing to the reduction of cardiovascular events with
icosapent ethyl are not completely understood and are likely
multi-factorial, previous studies have clearly demonstrated the
anti-inflammatory effects of EPA. The current analysis of REDUCE-IT
finds a difference in inflammatory markers between icosapent ethyl
and placebo, however, the absolute magnitude of these differences
is too small to explain the substantial reduction in clinical
events seen in the REDUCE-IT trial, which is most likely due to the
approximate 400% increase in EPA levels.”
Additionally, clinical studies suggest that IPE may be
contributing to plaque reduction, regression and stabilization in
patients with coronary artery disease.ii,iii,iv Additional studies
are needed to further elucidate any effects on plaque
characteristics. A prior randomized, cardiovascular outcomes trial
of EPA versus standard of care demonstrated that EPA provided a 19%
cardiovascular risk reduction in patients with normal triglyceride
levels and only lowered triglyceride levels by 5%, suggesting that
the effects of EPA go beyond triglyceride lowering.v
“While exploratory biomarker sub-analyses are interesting
scientifically, what is most clear and important clinically are the
cardiovascular outcomes results seen in the REDUCE-IT trial
overall,” said Nabil Abadir, MB. CH.B., Chief Medical Officer,
Amarin. “As we know, the REDUCE-IT trial demonstrated the clear
risk reduction benefits of icosapent ethyl in reducing
cardiovascular events among patients most at risk for
cardiovascular disease, especially those with prior cardiovascular
events such as heart attack or coronary revascularization
procedures.”
Added Dr. Abadir, “The landmark REDUCE-IT trial and its clinical
outcomes underpin the international regulatory approvals of
VASCEPA®/VAZKEPA® as well as the more than 25 clinical treatment
guidelines, consensus statements and scientific statements from
medical societies or journals around the globe that have been
updated recommending the use of icosapent ethyl in appropriate
at-risk patients. Based on the results of REDUCE-IT, regulatory
agencies granted approval of IPE for ASCVD risk reduction for
millions of high-risk patients with characteristics like those
enrolled and followed in the study.”
This REDUCE-IT post hoc biomarker sub-analysis was funded by
Amarin under a research grant.
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 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.vi The primary results of REDUCE-IT were published in
The New England Journal of Medicine in November 2018.vii The
total events results of REDUCE-IT were published in the Journal of
the American College of Cardiology in March 2019.viii These and
other publications can be found in the Science section on the
company’s website at www.amarincorp.com.
About VASCEPA® (icosapent ethyl)
CapsulesVASCEPA (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 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 more than 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, 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 statements
regarding the potential for VASCEPA (marketed as VAZKEPA in
Europe), as well as the potential role that IPE may have in
influencing inflammatory biomarkers and plaque reduction. 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
Investors and others should note that 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.
Amarin Contact Information Investor Inquiries:
Lisa DeFrancescoAmarin Corporation plc
IR@amarincorp.com (investor inquiries)
Media Inquiries: Mark MarmurAmarin Corporation plc
PR@amarincorp.com (media inquiries)
_________________________________________
- Amarin Press Release.
https://www.globenewswire.com/news-release/2020/03/31/2009038/0/en/Amarin-Highlights-VASCEPA-Icosapent-Ethyl-Related-Data-Presented-at-American-College-of-Cardiology-s-Annual-Scientific-Session-Together-With-World-Congress-of-Cardiology-ACC-20-WCC.html
- Budoff MJ, Bhatt DL, Kinninger A, et al. Effect of icosapent
ethyl on progression of coronary atherosclerosis in patients with
elevated triglycerides on statin therapy: final results of the
EVAPORATE trial. Eur Heart J. 2020; 41(40): 3925-3932.
- T. Watanabe, K. Ando, H. Daidoji, et al., CHERRY study
investigators. A randomized controlled trial of eicosapentaenoic
acid in patients with coronary heart disease on statins. Journal of
Cardiology. 2017;70:537-544.
http://www.journal-of-cardiology.com/article/S0914-5087(17)30200-9/fulltext
- YamanoT, Kubo T, Shiono Y, Shimamura K, OriiM, TanimotoT,
Matsuo Y, InoY, KitabataH, Yamaguchi T, Hirata K, Tanaka A,
ImanishiT, Akasaka T. Impact of eicosapentaenoic acid treatment on
the fibrous cap thickness in patients with coronary atherosclerotic
plaque: an optical coherence tomography study. J AtherosclerThromb.
2015;22(1):52-61.
https://www.jstage.jst.go.jp/article/jat/22/1/22_25593/_pdf/-char/en
- Yokoyama M, OrigasaH, MatsuzakiM, Matsuzawa Y, Saito Y,
Ishikawa Y, Oikawa S, Sasaki J, HishidaH, ItakuraH, Kita T,
KitabatakeA, NakayaN, Sakata T, Shimada K, ShiratoK; Japan EPA
lipid intervention study (JELIS) Investigators. Effects of
eicosapentaenoic acid on major coronary events in
hypercholesterolaemicpatients (JELIS): a randomisedopen-label,
blinded endpoint analysis. Lancet. 2007 Mar 31;369(9567):1090-8.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(07)60527-3/fulltext
- 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.
- 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.
- Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT
Investigators. Reduction in first and total ischemic events with
icosapent ethyl across baseline triglyceride tertiles. J Am Coll
Cardiol. 2019;74:1159-1161.
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Sep 2023 to Sep 2024