Amarin Corporation plc (NASDAQ:AMRN) today announced the
presentation of REDUCE-IT® CABG at American Heart Association’s
(AHA) Virtual Scientific Sessions 2020, being held virtually from
November 13 – November 17, 2020, adding to the growing body of
knowledge on the clinical impact of VASCEPA® (icosapent ethyl).
These new analyses supported by Amarin were presented by Subodh
Verma, M.D., Ph.D., FRCSC, Professor and Cardiac Surgeon at
University of Toronto.
“The REDUCE-IT CABG analysis results are another
piece of the puzzle when looking at the potential use of icosapent
ethyl in the procedural setting,” 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.
“The findings of benefit in at-risk patients with prior CABG are
consistent with previously presented data on overall reductions in
first and total coronary revascularization events, as well as in
patients with prior percutaneous coronary interventions, and
further strengthen the case for consideration of icosapent ethyl as
an additional intervention for use by physicians to care for this
patient population.”
The REDUCE-IT CABG analysis examined 1,837
(22.5%) of the patients enrolled in REDUCE-IT, representing all
patients who had undergone a prior coronary artery bypass grafting
(CABG) procedure, a common form of surgical intervention to help
treat coronary heart disease. Baseline characteristics were similar
among patients randomized to VASCEPA versus placebo. Post hoc
exploratory analyses of this subgroup showed that, for the
composite endpoint of 5-point MACE, which was the prespecified
primary endpoint for the full REDUCE-IT study cohort, time to first
event was significantly reduced with VASCEPA versus placebo by 24%
(p=0.004) and total (first and subsequent) events were also reduced
by 36% (p=0.0002). For the REDUCE-IT study’s key secondary
composite endpoint of 3-point MACE, time to first event was reduced
by 31% (p=0.001) in the subgroup of patients with a prior CABG.
Coronary revascularization procedures, such as
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 latest
statistical update from the American Heart Association (AHA) shows
that, in 2014, an estimated 371,000 inpatient CABG procedures were
performed in the United States with a mean inpatient hospital
charge for CABG of $168,541.1
“Revascularization procedures overall
significantly impact the healthcare system, with CABG procedures
adding to the burden and driving substantial costs,” said Steven
Ketchum, Ph.D., senior vice president and president, research &
development and chief scientific officer, Amarin. “The subgroup
data presented at AHA Virtual Scientific Sessions 2020 suggests
another way in which VASCEPA can possibly alleviate the significant
burden that at-risk patients and the healthcare system face with
CABG procedures and how VASCEPA therapy can potentially reduce the
risk of dangerous subsequent events.”
REDUCE-IT was not specifically powered to
examine individual cardiovascular endpoints or patient subgroups,
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.
These REDUCE-IT CABG results follow multiple
scientific presentations of analysis results from other important
patient subgroups in the REDUCE-IT study, including REDUCE-IT
REVASC2 and REDUCE-IT PCI. References to these other subgroup
analyses are available on Amarin’s website at
www.amarincorp.com.
Additional information on AHA Virtual Scientific
Sessions 2020 can be found here.
Audio Webcast InformationAmarin
will host an audio webcast on November 18, 2020, at 4:30 p.m. EST
to discuss this and other VASCEPA-related information presented
during the AHA Virtual Scientific Sessions 2020. To listen please
register here, listen live on the investor relations section of the
company's website at www.amarincorp.com, or via telephone by
dialing 877-407-8033 within the United States, 201-689-8033 from
outside the United States.
About AmarinAmarin 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%.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:Investor RelationsIn U.S.:
+1 (908) 719-1315Amarin Corporation plcIR@amarincorp.com (investor
inquiries)
Solebury Troutlstern@soleburytrout.com
Media Inquiries:Alina
KolomeyerCommunicationsAmarin Corporation plcIn U.S.: +1 (908)
892-2028 PR@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 Peterson BE, Bhatt DL, Steg PG, Miller
M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle
RT Jr, Granowitz C, Gibson CM, Pinto D, Giugliano RP, Budoff MJ,
Tardif JC, Verma S, Ballantyne CM; REDUCE-IT Investigators.
Reduction in Revascularization with Icosapent Ethyl: Insights from
REDUCE-IT REVASC. Circulation. 2020 Nov 5. doi:
10.1161/CIRCULATIONAHA.120.050276. Epub ahead of print. PMID:
33148016.3 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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