Amarin Corporation plc (NASDAQ:AMRN) today highlighted new data
describing the benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) on
coronary physiology, which was published in the European Heart
Journal - Cardiovascular Imaging, and plaque progression, which was
presented at the American Heart Association’s Vascular Discovery
2023 meeting in Boston, MA, May 10-13.
The studies and their key findings follow:
Benefit of Icosapent Ethyl on Coronary Physiology Assessed by
Computed Tomography Angiography Fractional Flow Reserve:
EVAPORATE-FFRCT
The EVAPORATE trial assessed the efficacy of VASCEPA/VAZKEPA in
reducing plaque burden among patients on stable statin therapy with
known angiographic coronary artery disease (CAD). EVAPORATE
demonstrated that in statin-treated patients, VASCEPA/VAZKEPA
significantly reduced plaque burden measured by serial coronary
computed tomography angiography (CTA) compared with placebo.
The objective of the EVAPORATE- FFRCT study, which appeared
online in the European Heart Journal - Cardiovascular Imaging, was
to assess the impact of VASCEPA/VAZKEPA on coronary physiology
assessed by fractional flow reserve derived from coronary CTA data
sets (FFRCT) using imaging data from EVAPORATE.i FFRCT has been
associated with various clinical outcomes, such as the safe
deferral of invasive coronary angiography, cardiovascular death or
myocardial infarction, and revascularizationii,iii.
This study is the first assessment of FFRCT to determine drug
effect, and there was significant improvement in the pre-specified
primary endpoint of FFRCT value in the distal coronary segment from
baseline to follow-up in the most diseased vessel per patient using
VASCEPA/VAZKEPA compared with placebo. VASCEPA/VAZKEPA improved
mean distal segment FFRCT at 9- and 18-months follow-up compared
with placebo (P = 0.02, P = 0.03 respectively). The secondary
endpoint, change in translesional FFRCT (Δ FFRCT across the most
severe (minimum 30%) diameter stenosis) coronary lesion per vessel
was improved with VASCEPA/VAZKEPA treatment compared with placebo,
although it was not statistically significant (P = 0.054).
“The early and sustained improvement in FFRCT at 9- and
18-months follow-up provides mechanistic insight into the clinical
benefit observed in the REDUCE-IT trial, which demonstrated that
VASCEPA/VAZKEPA significantly reduced ischemic events in
statin-treated patients with atherosclerosis or diabetes and
elevated triglycerides, including large reductions in myocardial
infarction and elective, urgent, and emergent coronary
revascularization,” said cardiologist Mark G. Rabbat, MD, Professor
of Medicine and Radiology and Director of Cardiac Computed
Tomography (CT) at Loyola University in Chicago and lead author of
the study. “Additionally, as this is the first assessment of FFRCT
to determine drug effect, it has potentially important implications
in utilizing FFRCT to predict treatment response.”
Effect of Icosapent Ethyl on In Vivo Atheroma Progression and
Inflammatory Protease Activity
This animal study found that VASCEPA/VAZKEPA reduced in vivo
plaque progression versus control (P=0.03) as measured by
intravascular ultrasound (IVUS) and plaque cathepsin protease
activity (P=0.005) measured by near-infrared fluorescence (NIRF)
molecular imaging. On fluorescence microscopy, plaques from animals
treated with VASCEPA/VAZKEPA exhibited fewer macrophages (P=0.04).
The findings were presented by Mohamad Kassab, MD, in an oral
presentation at the American Heart Association’s Vascular Discovery
meeting on May 11, 2023.
“This study, which shows that VASCEPA/VAZKEPA reduces in vivo
plaque progression, plaque cathepsin protease activity and plaque
macrophages, provides novel experimental evidence supporting the
anti-atherosclerosis and anti-inflammatory effects of the
medication.
However, in vivo mechanisms underlying these effects remain
somewhat unclear,” said Farouc Jaffer, MD PhD, Director,
Massachusetts General Hospital Coronary Intervention and Chronic
Total Occlusion PCI Program, Boston, Massachusetts.
“These new findings from two different studies provide important
mechanistic information about VASCEPA/VAZKEPA and further elucidate
its value in reducing cardiovascular events in at-risk patients,”
said Nabil Abadir, MB. CH.B., Chief Medical Officer and Head of
Global Medical Affairs, Amarin. "At Amarin, we’re focused on
improving the lives of those with cardiovascular disease. We are
proud to add to the body of research that further demonstrates the
benefit of VASCEPA/VAZKEPA."
About AmarinAmarin is an innovative
pharmaceutical company leading a new paradigm in cardiovascular
disease management. We are committed to increasing the scientific
understanding of the cardiovascular risk that persists beyond
traditional therapies and advancing the treatment of that risk for
patients worldwide. 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.
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.iv 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%.v 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.vi,vii,viii
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.ix The primary results of
REDUCE-IT were published in The New England Journal of Medicine in
November 2018.x The total events results of REDUCE-IT were
published in the Journal of the American College of Cardiology in
March 2019.xi 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 more than 20 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, 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. VAZKEPA is being commercialized in multiple European
countries, including England, Wales, Sweden and Finland.
United States Indications 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 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 Amarin’s key achievements in 2022
and the potential impact and outlook for achievements in 2023 and
beyond; Amarin’s 2023 financial outlook and cash position; Amarin’s
overall efforts to expand access and reimbursement to VAZKEPA
across global markets; and the overall potential and future success
of VASCEPA/VAZKEPA and Amarin generally. 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 Amarin
communicates with its investors and the public using the company
website (www.amarincorp.com) and the investor relations website
(amarincorp.gcs-web.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: Lisa DeFrancesco Investor Relations Amarin
Corporation plc
investor.relations@amarincorp.com (investor
inquiries)
Media Inquiries: Mark Marmur Corporate Communications, Amarin
Corporation plc
PR@amarincorp.com (media
inquiries)
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.
References
i Rabbat MG, Lakshmanan S, Benjamin MM, Doros G, Kinninger A,
Budoff MJ, Bhatt DL. Benefit of icosapent ethyl on coronary
physiology assessed by computed tomography angiography fractional
flow reserve: EVAPORATE-FFRCT. Eur Heart J Cardiovasc Imaging. 2023
Apr 21ii Rabbat M, Leipsic J, Bax J, et al. Fractional Flow Reserve
Derived from Coronary Computed Tomography Angiography Safely Defers
Invasive Coronary Angiography in Patients with Stable Coronary
Artery Disease. J Clin Med. 2020;9(2):604. Published 2020 Feb
24.iii Patel MR, Nørgaard BL, Fairbairn TA, et al. 1-Year Impact on
Medical Practice and Clinical Outcomes of FFRCT: The ADVANCE
Registry. JACC Cardiovasc Imaging. 2020;13(1 Pt 1):97-105.iv
American Heart Association. Heart Disease and Stroke
Statistics—2020 Update: A Report From the American Heart
Association. Circulation. 2020;141:e139-e596.v 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.vi Budoff M. Triglycerides and triglyceride-rich
lipoproteins in the causal pathway of cardiovascular disease. Am J
Cardiol. 2016;118:138-145.vii 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.viii Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.ix 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.x 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.xi 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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