Amarin Corporation plc (NASDAQ:AMRN) today announced the
presentation of REDUCE-IT® PCI at Transcatheter Cardiovascular
Therapeutics (TCT) Connect, the 32nd annual scientific symposium of
the Cardiovascular Research Foundation, being held virtually from
October 14 – October 18, 2020 adding to the growing body of
knowledge on the clinical impact of VASCEPA® (icosapent ethyl).
These new analyses supported by Amarin were presented during the
TCT Connect 2020 Best of Abstracts session by Benjamin E. Peterson,
M.D., Brigham and Women’s Hospital Heart & Vascular Center and
Harvard Medical School.
“The opportunity to further explore REDUCE-IT
data and effects in those patients with prior PCI provides
additional understanding of the potential benefit of icosapent
ethyl in the clinical 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 and
senior author of the REDUCE-IT PCI analyses. “The findings of
benefit in at-risk patients with prior PCI are consistent with
previously presented data on overall reductions in first and total
coronary revascularization events of 34% and 36%, respectively.
Moreover, the statistically significant substantial benefit in
reduced coronary revascularization procedures seen as early as 11
months provides clinicians with a potential additional intervention
in a patient population for whom time is of the essence.”
The REDUCE-IT PCI analysis looked at 3,408
(41.7%) of patients enrolled in REDUCE-IT who had undergone a prior
PCI. These patients were randomized a median of 2.9 years after
PCI. Baseline characteristics were similar among patients
randomized to VASCEPA versus placebo. Post hoc exploratory analyses
of the subgroup of 3,408 patients with a prior PCI showed that, for
the primary composite endpoint of 5-point MACE, time to first event
was significantly reduced with VASCEPA versus placebo by 34%
(p<0.0001) and total (first and subsequent) events were also
reduced by 39% (p<0.0001). For the key secondary composite
endpoint of 3-point MACE, time to first event was reduced by 34%
(p<0.0001) in the subgroup of patients with a prior PCI.
Coronary revascularization procedures, such as
stenting, 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 480,000 inpatient PCI
procedures were performed in the United States with a mean
inpatient hospital charge for PCI of $84,813.1
“Revascularization procedures overall
significantly impact the healthcare system, with PCI 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 TCT Connect 2020 reflect new findings
demonstrating the substantial impact of VASCEPA on at-risk patients
in REDUCE-IT with prior PCI procedures and how the therapy can help
avoid subsequent events that could have dire
consequences.”
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.
The presentation as well as additional
information on TCT Connect 2020 can be found here.
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) 719-1315
IR@amarincorp.com (investor inquiries)
Lee M. SternSolebury TroutIn U.S.: +1 (646)
378-2992 lstern@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 |
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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