Amarin Corporation plc (NASDAQ:AMRN) supported new data, presented
at ESC Congress 2020, the annual meeting of the European Society of
Cardiology (ESC), held from August 29 - September 1, 2020, adding
to the growing body of knowledge on VASCEPA® (icosapent ethyl) in
patients at risk for major adverse cardiovascular events.
“Cardiovascular disease continues to impact and
challenge us all,” said Craig Granowitz, M.D., Ph.D., Amarin’s
senior vice president and chief medical officer. “We see the
detrimental effects it has on patients and those who care for them,
as well as healthcare systems around the world. Data presented at
ESC Congress 2020 provides additional support for potential ways in
which VASCEPA can help to alleviate the burden of the worldwide
public health crisis that is cardiovascular disease.”
Key data presented at ESC Congress
2020
“Effect of Icosapent Ethyl on Progression of
Coronary Atherosclerosis in Patients with Elevated Triglycerides on
Statin Therapy: Final results of the EVAPORATE Study” – presented
on behalf of all authors by Matthew Budoff, M.D., The Lundquist
Institute
Highlights: VASCEPA
demonstrated significant, 17% regression of low attenuation plaque
(LAP) volume on multidetector computed tomography (MDCT) compared
with placebo over 18 months.
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.
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 of these forms of
coronary plaque 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). VASCEPA is the first and only agent studied on top of
statin therapy reported to exhibit coronary plaque regression in
hypertriglyceridemic patients.
The presentation is available here and has been
published in European Heart Journal.
“REDUCE-IT: Accumulation of Data Across
Prespecified Interim Analyses to Final Results” – presented on
behalf of all authors by Brian Olshansky, M.D., University of
Iowa
Highlights: The presentation at
ESC Congress 2020 was the first presentation of results from the
pre-specified interim analyses for the landmark REDUCE-IT®
cardiovascular outcomes study. An independent, unblinded DMC (Data
and Safety Monitoring Committee) performed interim analyses of data
during the REDUCE-IT cardiovascular outcomes study at approximately
60% and 80% (2.9 and 3.7 years of median primary endpoint
follow-up, respectively), with a final analysis at 4.9 years median
follow-up. Primary and key secondary endpoints were the reduction
in the first occurrence of composite of 5-point (cardiovascular
death, myocardial infarction [MI], stroke, coronary
revascularization or unstable angina) and 3-point (cardiovascular
death, MI, stroke) major adverse cardiovascular events (MACE).
Highly statistically significant outcomes were
achieved for both primary and key secondary composite endpoints at
the first interim, persisted at the second interim, and fully
evolved at the final analysis. Consistent, statistically
significant outcome measures demonstrating the robust and early
benefit of icosapent ethyl were evident for the primary composite
endpoint starting at 21 months, and for the key secondary composite
endpoint at 25 months. Allowing the REDUCE-IT dataset to mature
fully provided physicians and patients with robust, consistent, and
reliable efficacy and safety data upon which to base clinical
decisions for icosapent ethyl in cardiovascular risk reduction.
“REDUCE-IT: Total Ischemic Events Reduced Across
the Full Range of Baseline LDL-Cholesterol and Other Key Subgroups”
– presented on behalf of all authors by Deepak L. Bhatt, M.D.,
M.P.H., Brigham and Women’s Hospital
Highlights: VASCEPA
administered at 4 g/day in the REDUCE-IT cardiovascular outcomes
study, as previously reported, significantly reduced total ischemic
events in statin-treated patients with elevated triglycerides and
other cardiovascular risk factors despite well-controlled LDL-C
(<100 mg/dL). Presented at ESC Congress 2020 was that, similar
to the results of analyses of first occurrences of MACE, reductions
in total (first and subsequent) occurrences of MACE were observed
across a variety of predefined subgroups, including baseline levels
of triglycerides and LDL-C, with substantial reductions across
already low LDL-C tertiles in both primary (5-point MACE) and key
secondary (3-point MACE) endpoints, as well as in the subgroups
with or without elevated hsCRP or low HDL and elevated
triglycerides at baseline.
“Are the Results of Clinical Trials Relevant in
The Real World? The Applicability of REDUCE-IT to the FAST-MI
Registry.” – presented on behalf of all authors by Jean Ferrières,
M.D., M.Sc., FESC, Toulouse Rangueil University Hospital
Highlights: In order to
evaluate the applicability of results of the REDUCE-IT
cardiovascular outcomes study in a French population, the inclusion
and exclusion criteria of this landmark study were applied to
French patients who were admitted to coronary or intensive care
units within 48 hours of symptom onset during a 1-month period
(Registry on Acute ST-elevation and non-ST-elevation Myocardial
Infarction (FAST-MI), 2010 and 2015). The results support that,
even in this limited registry of patients, many French patients
would qualify for the inclusion criteria of REDUCE-IT in which
patients treated with VASCEPA experienced significant reductions in
major adverse cardiovascular events.
“REDUCE-IT: Outcomes by Baseline Statin Type” –
presented on behalf of all authors by Deepak L. Bhatt, M.D.,
M.P.H., Brigham and Women’s Hospital
Highlights: The objectives of
this analysis were to explore the impact of baseline and
concomitant statin type on atherosclerotic cardiovascular disease
(ASCVD) outcomes and on LDL-C and ApoB levels in the results of the
REDUCE-IT cardiovascular outcomes study. The exploratory analysis
examined the primary and key secondary endpoints of REDUCE-IT by
individual statin type: atorvastatin, simvastatin, rosuvastatin,
pravastatin, lovastatin, fluvastatin, or pitavastatin; and by
statin category: lipophilic (i.e., hydrophobic: atorvastatin,
simvastatin) vs. lipophobic (i.e., hydrophilic: rosuvastatin,
pravastatin). Icosapent ethyl demonstrated similar benefits vs.
placebo across all individual baseline statin types and both
lipophilic and lipophobic statin categories. Individual baseline
statin type and lipophilic/lipophobic category had no meaningful
impact on the modest median LDL-C changes from baseline to 1 year
and ApoB changes from baseline to 2 years observed with VASCEPA vs.
placebo. Primary and key secondary composite endpoint outcomes and
changes in LDL-C and ApoB by concomitant statin use yielded similar
results. These data provide clinicians with additional insight
regarding concomitant statin therapy considerations when
prescribing icosapent ethyl and suggest there are important
mechanisms of action for the substantial ASCVD risk reduction
observed with VASCEPA that are distinct from the LDL-C receptor
pathway.
All analyses highlighted above were funded by
Amarin.
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.1 In aggregate, there are more than 2.4
million major adverse cardiovascular events per year from
cardiovascular disease or, on average, one 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%.2 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.3,4,5
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.6 The primary results of REDUCE-IT were published in The
New England Journal of Medicine in November 2018.7 The total events
results of REDUCE-IT were published in the Journal of the American
College of Cardiology in March 2019.8 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 American Heart Association. Heart Disease and Stroke
Statistics—2020 Update: A Report From the American Heart
Association. Circulation. 2020;141:e139–e596.2 Ganda OP,
Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia
therapy in hypertriglyceridemia management. J Am Coll Cardiol.
2018;72(3):330-343.3 Budoff M. Triglycerides and
triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol. 2016;118:138-145.4
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):e008740.5 Nordestgaard BG.
Triglyceride-rich lipoproteins and atherosclerotic cardiovascular
disease - New insights from epidemiology, genetics, and biology.
Circ Res. 2016;118:547-563.6 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;40:138-148.7
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;380:11-22.8 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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