Amarin Corporation plc (NASDAQ:AMRN) today announced that the
Chinese Society of Cardiology (CSC) has included icosapent ethyl in
its updated Guidelines for Primary Prevention of Cardiovascular
Diseases for 2021 as published in the Chinese Journal of
Cardiovascular Diseases. The guideline authors include “icosapent
ethyl 2 grams twice a day (as studied in REDUCE-IT®) as a treatment
consideration to further lower atherosclerotic cardiovascular
disease (ASCVD) in the appropriate patient population.”1
“Inclusion of icosapent ethyl in the CSC
treatment guidelines further validates the increasing independent
support and acceptance of this unique drug to reduce
cardiovascular risk,” stated Craig B. Granowitz, M.D., Ph.D.,
senior vice president and chief medical officer of Amarin.
“Importantly, these updated guidelines also support that the
preventive effect of omega-3 fatty acids on ASCVD is not only
related to the dose, but also to the type and formulation of
omega-3 fatty acid and incorporates findings from the REDUCE-IT
cardiovascular outcomes study of VASCEPA®.”
“With this new recommendation, icosapent ethyl
is now included in the treatment guidelines or otherwise
recommended for use by 13 medical associations internationally,
solidifying its role as an important treatment option beyond
cholesterol management for millions of patients worldwide at risk
for a cardiovascular event,” added Dr. Granowitz. Similar to
Europe, where the European Society of Cardiology and the European
Atherosclerosis Society added icosapent ethyl to their medical
treatment guidelines prior to completion of the ongoing regulatory
submission and review processes for VASCEPA (icosapent ethyl), CSC
inclusion of icosapent ethyl in its updated treatment guidelines
has been made separate from and in advance of completion of the
analogous regulatory processes for VASCEPA in China.
In November 2020, Amarin shared positive,
statistically significant top-line results from a Phase 3 clinical
trial of VASCEPA conducted in China by Amarin’s partner, Edding.
The study, which investigated VASCEPA as a treatment for patients
with very high triglycerides (≥500 mg/dL), met its primary efficacy
endpoint and demonstrated a safety profile similar to placebo. This
pivotal study mirrored Amarin’s MARINE study in patients from the
United States and other countries and showed consistency across the
Chinese and non-Chinese study populations. These findings will
provide support as Edding progresses towards and through the next
steps of regulatory submission and review of VASCEPA for potential
approval in Mainland China.
The CSC recommendation is classified as a
Category IIa recommendation denoting that icosapent ethyl is useful
and effective and should be considered for treatment of at-risk
patients. The classification is an Evidence Level B recommendation
which reflects that the evidence comes from a single randomized
trial or multiple large non-randomized studies. CSC cited that its
recommendations are supported by the results of the REDUCE-IT
cardiovascular outcomes study. The CSC does not provide
endorsements of any brand name commercial product. Accordingly, CSC
Guidelines for Primary Prevention of Cardiovascular Diseases
reference icosapent ethyl. The CSC guideline does not reference
VASCEPA, the brand name of icosapent ethyl in the United States,
and such guideline should not be construed as an endorsement or
approval by the CSC of VASCEPA.
Amarin acknowledges the rigor with which the
Guidelines for Primary Prevention of Cardiovascular Diseases are
crafted and approved by the CSC, which is comprised of leading
medical professionals in China who specialize in the care of
patients with cardiovascular disease.
The complete 2021 updates to the Guidelines for
Primary Prevention of Cardiovascular Diseases from the CSC can be
accessed online here.
About Hypertriglyceridemia in
ChinaThere were approximately 180.4 million
hypertriglyceridemia (HTG) patients in China in 2019, representing
approximately 20.2% of the adult population. Among all HTG patients
in China, there were approximately 9 million adults who had very
high TG levels (≥500 mg/dL). In 2019, there were approximately 36.1
million statin-treated adult patients in China with elevated TG
levels (≥150 mg/dL) and either established CVD or diabetes mellitus
and two or more additional risk factors for CVD, the addressable
patients of the U.S. FDA-approved indication for reducing CV events
of VASCEPA in China.
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 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.2 The primary results of REDUCE-IT were published in The
New England Journal of Medicine in November 2018.3 The total events
results of REDUCE-IT were published in the Journal of the American
College of Cardiology in March 2019.4 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 U.S. 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 U.S. 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 RelationsAmarin
Corporation plcIn U.S.: +1 (908) 719-1315 IR@amarincorp.com
(investor inquiries)
Solebury Troutamarinir@troutgroup.com
Media Inquiries:Alina
KolomeyerCommunicationsAmarin Corporation plcIn U.S.: +1 (908)
892-2028 PR@amarincorp.com (media inquiries)
________________________________
1 Cardiovascular Branch of Chinese Medical
Association, Cardiac Prevention and Rehabilitation Professional
Committee of Chinese Rehabilitation Medicine Association, Chinese
Gerontology and Elderly Cardiology Committee of the National
Medical Association, et al. Guidelines for Primary Prevention of
Cardiovascular Diseases in China. Chinese Journal of Cardiovascular
Diseases. 2020;48(12):1000-1038.2 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;40:138-148.3 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;380:11-22.4 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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