Amarin Corporation plc (NASDAQ:AMRN) today announced that the trial
results from Effect of Icosapent Ethyl on Progression of Coronary
Atherosclerosis in Patients with Elevated Triglycerides on Statin
Therapy: Final results of the EVAPORATE Trial were presented at ESC
Congress 2020, the annual meeting of the European Society of
Cardiology, on August 29, 2020, 9:13 am CEST (Central European
Summer Time) by Matthew Budoff, M.D., Director of Cardiovascular CT
at The Lundquist Institute and Professor of Medicine at the David
Geffen School of Medicine at UCLA, the study sponsor. VASCEPA®
(icosapent ethyl) demonstrated significant, 17% regression of low
attenuation plaque (LAP) volume on multidetector computed
tomography (MDCT) compared with placebo over 18 months. As
referenced below, these final results can be found in the
concurrent publication in European Heart Journal.
“EVAPORATE provides important mechanistic data
on coronary plaque characteristics that are potentially relevant to
the overall REDUCE-IT® results and clinical use of icosapent
ethyl,” commented Matthew Budoff, M.D., Director of Cardiovascular
CT at The Lundquist Institute and Professor of Medicine at the
David Geffen School of Medicine at UCLA. “The REDUCE-IT REVASC
analysis presented at American Society for Preventive Cardiology
last month reported an early coronary revascularization benefit
signal with sustained statistical significance attained by 11
months. EVAPORATE is the first demonstration of imaging results
with icosapent ethyl using MDCT. The coronary plaque reduction
shown in EVAPORATE is consistent with the benefits of icosapent
ethyl in cardiovascular event outcomes shown in REDUCE-IT, a
separate study.”
A total of 80 patients were enrolled in the
randomized, double-blind, placebo-controlled EVAPORATE trial.
Patients had to have coronary atherosclerosis as documented by MDCT
(1 or more angiographic stenoses with ≥20% narrowing), be on statin
therapy, and have persistently elevated triglyceride (TG) levels
(mean TG at baseline was 259.1 mg/dL [+/- 78.1]). Patients
underwent an interim scan at 9 months and a final scan at 18
months. The prespecified primary endpoint was a comparison of
change in LAP volume at 18 months between icosapent ethyl and
placebo. EVAPORATE was not powered for long-term outcomes.
The final results showed a significant reduction
in the primary endpoint; icosapent ethyl reduced LAP plaque volume
by 17% from baseline to the 18-month scan, whereas there was a
progression of LAP plaque volume in the placebo group. There were
significant differences between icosapent ethyl and placebo at
study end for secondary endpoints of other types of plaque volume
changes, including and sequentially total, total non-calcified,
fibrofatty, and fibrous plaque volumes. All regressed in the
icosapent ethyl group and progressed in the placebo group,
(p<0.01 for all). The only secondary endpoint which did not
achieve a significant difference between groups in multivariable
modeling was dense calcium (p=0.053).
The mineral oil placebo, used for consistency
with REDUCE-IT, was also analyzed against plaque changes from
baseline in another placebo in a separate study. Rates of plaque
changes in patients randomized to mineral oil (the placebo cohort)
in the EVAPORATE study were compared with rates of plaque changes
in the placebo arm of a second study that used a cellulose-based
placebo. There was no difference in plaque progression between
mineral oil and cellulose based placebos.1
“Coronary plaque regression is an important
finding with VASCEPA and may explain, in part, the substantial
cardiovascular benefit seen in REDUCE-IT,” said Craig Granowitz,
M.D., Ph.D., Amarin’s senior vice president and chief medical
officer. “The EVAPORATE study results potentially shed further
light on how VASCEPA works to lower residual cardiovascular
risk.”
Limitations of this single study include a small
sample size. More study is needed to demonstrate the effects of
VASCEPA on coronary plaque to determine the relationship of such
effects, if any, on cardiovascular risk reduction.
The presentation will be available here with a
concurrent publication in European Heart Journal.
Financial Disclosure Funding
from Amarin was provided to the sponsor of the EVAPORATE study, The
Lundquist Institute, for Dr. Matthew Budoff’s work on the
study.
About Amarin Amarin Corporation
plc is a rapidly growing, innovative pharmaceutical company focused
on developing and commercializing therapeutics to cost-effectively
improve cardiovascular health. Amarin’s lead product, VASCEPA®
(icosapent ethyl), is available by prescription in the United
States, Canada, Lebanon and the United Arab Emirates. VASCEPA is
not yet approved and available in any other countries. Amarin, on
its own or together with its commercial partners in select
geographies, is pursuing additional regulatory approvals for
VASCEPA in China, Europe and the Middle East. For more information
about Amarin, visit www.amarincorp.com.
About Cardiovascular RiskThe
number of deaths in the United States attributed to cardiovascular
disease continues to rise. There are 605,000 new and 200,000
recurrent heart attacks per year (approximately 1 every 40
seconds), in the United States. Stroke rates are 795,000 per year
(approximately 1 every 40 seconds), accounting for 1 of every 19
U.S. deaths. Cardiovascular disease results in 859,000 deaths per
year in the United States.2 In aggregate, there are more than 2.4
million major adverse cardiovascular events per year from
cardiovascular disease or, on average, 1 every 13 seconds in the
United States alone.
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%.3 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.4,5,6
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.7 The primary results of REDUCE-IT were published in The
New England Journal of Medicine in November 2018.8 The total events
results of REDUCE-IT were published in the Journal of the American
College of Cardiology in March 2019.9 These and other publications
can be found in the R&D section on the company’s website at
www.amarincorp.com.
About VASCEPA®
(icosapent ethyl) CapsulesVASCEPA (icosapent
ethyl) capsules are the first-and-only prescription treatment
approved by the FDA comprised solely of the active ingredient,
icosapent ethyl (IPE), a unique form of eicosapentaenoic acid.
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 eight million times. VASCEPA is
covered by most major medical insurance plans. The new,
cardiovascular risk indication for VASCEPA was approved by the FDA
in December 2019.
Indications and Limitation of UseVASCEPA 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:
Effect of VASCEPA on Time to First
Occurrence of Cardiovascular Events in Patients with
Elevated Triglyceride levels and Other Risk Factors for
Cardiovascular Disease in REDUCE-IT
|
VASCEPA |
Placebo |
VASCEPA vs Placebo |
N = 4089n (%) |
Incidence Rate (per 100 patient years) |
N = 4090n (%) |
Incidence Rate (per 100 patient years) |
Hazard Ratio (95% CI) |
Primary composite endpoint |
Cardiovascular death, myocardial infarction, stroke, coronary
revascularization, hospitalization for unstable angina (5-point
MACE) |
705(17.2) |
4.3 |
901(22.0) |
5.7 |
0.75(0.68, 0.83) |
Key secondary composite endpoint |
Cardiovascular death, myocardial infarction, stroke (3-point
MACE) |
459(11.2) |
2.7 |
606(14.8) |
3.7 |
0.74(0.65, 0.83) |
Other secondary endpoints |
Fatal or non-fatal myocardial infarction |
250(6.1) |
1.5 |
355(8.7) |
2.1 |
0.69(0.58, 0.81) |
Emergent or urgent coronary revascularization |
216(5.3) |
1.3 |
321(7.8) |
1.9 |
0.65(0.55, 0.78) |
Cardiovascular death [1] |
174(4.3) |
1.0 |
213(5.2) |
1.2 |
0.80(0.66, 0.98) |
Hospitalization for unstable angina [2] |
108(2.6) |
0.6 |
157(3.8) |
0.9 |
0.68(0.53, 0.87) |
Fatal or non-fatal stroke |
98(2.4) |
0.6 |
134(3.3) |
0.8 |
0.72(0.55, 0.93) |
[1] Includes adjudicated cardiovascular deaths and deaths of
undetermined causality.[2] Determined to be caused by myocardial
ischemia by invasive/non-invasive testing and requiring emergent
hospitalization. |
FULL VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Forward-Looking Statements This
press release contains forward-looking statements, including
statements regarding the potential impact of VASCEPA in various
clinical uses. These forward-looking statements are not promises or
guarantees and involve substantial risks and uncertainties. Among
the factors that could cause actual results to differ materially
from those described or projected herein include the following:
uncertainties associated generally with research and development
and clinical trials such as further clinical evaluations failing to
confirm earlier findings. 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 its most recent Quarterly Report
on Form 10-Q. Existing and prospective investors are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Amarin undertakes no obligation
to update or revise the information contained in this press
release, 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
AmarinInvestors and others should note that Amarin
communicates with its investors and the public using the company
website (www.amarincorp.com), the investor relations website
(investor.amarincorp.com), including but not limited to investor
presentations and investor 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
InformationInvestor Inquiries:Elisabeth SchwartzInvestor
RelationsAmarin Corporation plcIn U.S.: +1 (908)
719-1315IR@amarincorp.com (investor inquiries)
Lee M. SternSolebury TroutIn U.S.: +1 (646)
378-2992lstern@soleburytrout.com
Media Inquiries:Alina
KolomeyerCommunicationsAmarin Corporation plcIn U.S.: +1 (908)
892-2028PR@amarincorp.com (media inquiries)
______________________________
1 Lakshmanan S, Shekar C, Kinninger A, et al.
Comparison of mineral oil and non-mineral oil placebo on coronary
plaque progression by coronary computed tomography angiography.
Cardiovasc Res. 2020;116(3):479-482.
2 American Heart Association. Heart Disease and Stroke
Statistics—2020 Update: A Report From the American Heart
Association. Circulation. 2020;141:e139–e596.
3 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.
4 Budoff M. Triglycerides and triglyceride-rich
lipoproteins in the causal pathway of cardiovascular disease. Am J
Cardiol. 2016;118:138-145.
5 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.
6 Nordestgaard BG. Triglyceride-rich lipoproteins and
atherosclerotic cardiovascular disease - New insights from
epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.
7 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.
8 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.
9 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.
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