Amarin Corporation plc (NASDAQ:AMRN) today announced that data from
the REDUCE-IT® REVASC analysis, presented as an encore by Deepak L.
Bhatt, M.D., M.P.H., Brigham and Women’s Hospital Heart &
Vascular Center and Harvard Medical School, at The American Society
for Preventive Cardiology 2020 Virtual Summit on CVD Prevention,
showed that administration of 4 g/day of VASCEPA® (icosapent ethyl)
resulted in a significant 34% reduction in first coronary
revascularizations versus placebo (p<0.0001). Similar reductions
of 36% were observed in total, or first and subsequent,
revascularizations (p<0.0001). In newly presented data, an early
coronary revascularization benefit signal was shown in a
prespecified exploratory analysis, with sustained statistical
significance attained by 11 months.
“The opportunity to build upon findings first
presented at the Society for Cardiovascular Angiography &
Intervention 2020 Scientific Sessions is important as we grow the
body of evidence supporting the role of icosapent ethyl in reducing
cardiovascular risk,” commented Dr. 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 the
REDUCE-IT REVASC analyses. “The additional data presented showing
very early timing of benefit and consistent statistically
significant substantial benefit as early as 11 months, coupled with
the interim EVAPORATE analysis showing early changes in most plaque
measurements at 9 months, allow for advancing insight into the
connectivity between the mechanism of action and clinical outcomes
of icosapent ethyl.”
Coronary revascularization procedures, such as
stenting and coronary artery bypass grafts (CABG), are invasive,
carry multiple risks, and can have significant direct and indirect
costs. Patients with elevated triglycerides despite statin therapy
have increased risk for ischemic events, including coronary
revascularizations. These procedures, whether pre-scheduled or
performed in an emergency, inevitably result in additional time
spent in a healthcare setting.
The analyses from the REDUCE-IT trial included
several types of coronary revascularization in statin-treated
patients with persistently elevated triglycerides (135-499 mg/dL),
who also had either cardiovascular disease or diabetes and
additional cardiovascular risk factors. Prespecified tertiary
endpoint analyses showed that times to first revascularization
events were significantly reduced by VASCEPA versus placebo across
subtypes of intervention, including elective, urgent, and emergent
revascularizations, which were reduced by 32% (p<0.0001), 34%
(p<0.0001), and 38% (p=0.02), respectively. In post hoc
analyses, VASCEPA significantly reduced percutaneous coronary
intervention (PCI) by 32% (p<0.0001) and CABG by 39% relative to
placebo (p=0.0005).
“Revascularization procedures significantly
impact the healthcare system,” said Steven Ketchum, Ph.D., senior
vice president and president, research & development and chief
scientific officer, Amarin. “These data reflect results consistent
with FDA-approved findings that continue to support that the use of
VASCEPA has the potential to transform cardiovascular care in
appropriate high-risk patients.”
REDUCE-IT was not specifically powered to
examine individual cardiovascular endpoints, therefore p-values
presented for these revascularization analyses are nominal and
exploratory with no adjustment for multiple comparisons. In
addition, coronary revascularization as an endpoint can sometimes
be considered subjective; however, these endpoints were adjudicated
by an independent, blinded clinical endpoint committee. Results
from the total coronary revascularization events analyses are
consistent across the various recurrent event statistical models
and are also consistent with the first coronary revascularization
events results. Together, the REDUCE-IT first and total coronary
revascularization events results support the robustness and
consistency of the clinical benefit of VASCEPA therapy in reducing
coronary revascularization.
The presentation is available at
https://www.aspcvirtualsummit.org/abstract-106.
Financial Disclosure
Funding from Amarin was provided to Brigham and
Women’s Hospital for Dr. Deepak L. Bhatt’s work as the REDUCE-IT
study chair and global principal investigator.
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. Amarin, together with its
commercial partners in select geographies, is pursuing additional
regulatory approvals for VASCEPA in China, the European Union and
the Middle East. For more information about Amarin, visit
www.amarincorp.com.
About Cardiovascular Risk
The 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, this is 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) Capsules
VASCEPA (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 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.
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 = 4089 n (%) |
Incidence Rate (per 100 patient years) |
N = 4090 n (%) |
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
Amarin
Investors 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 Information
Investor 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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