Amarin Corporation plc (NASDAQ:AMRN) today announced that its
corporate partner in China, Edding, has progressed VASCEPA®
(icosapent ethyl) into commencement of the regulatory review
processes in Mainland China and Hong Kong.
In Mainland China, the Chinese National Medical
Products Administration (NMPA) has accepted for review the new drug
application (NDA) for VASCEPA. Edding is seeking labeling based on
the entirety of clinical data available for VASCEPA, including the
previously announced successful results of the Phase 3 study
conducted by Edding as well as studies conducted by Amarin. Edding
currently anticipates receiving a decision in Mainland
China near the end of 2021.
In Hong Kong, on a separate track, the Hong Kong
Department of Health is evaluating VASCEPA based on current
approvals in the United States and Canada. The review process in
Hong Kong is anticipated to conclude near the end of 2021.
“We congratulate our partner, Edding, on the
advancements made in the regulatory submission and review processes
of VASCEPA in Mainland China and Hong Kong,” stated Steven Ketchum,
Ph.D., senior vice president and president, research &
development and chief scientific officer, Amarin. “The progress
made is important for our vision of offering the unique benefits of
VASCEPA to at-risk patients throughout the world. We look forward
to the potential of introducing, through Edding, this important
treatment option in Mainland China and Hong Kong.”
“We are very glad to know that the applications
for drug approval of VASCEPA were formally accepted by the National
Medical Products Administration (NMPA) in Mainland China and the
Department of Health in Hong Kong,” stated James He, chief medical
officer, Edding. “Prevention and treatment of cardiovascular
disease (CVD) is one of the major initiatives promoted by Health
China 2030. However, few new CVD medications other than statins
were launched in the market during the past several decades. In
November 2020, Edding announced the positive, statistically
significant top-line results of the Phase 3 clinical trial
conducted in Mainland China. We will continue working with Amarin
to bring this cross-era innovative drug into China to benefit
Chinese patients.”
About Amarin Amarin is a
rapidly growing, innovative pharmaceutical company leading a new
paradigm in cardiovascular disease management. From our scientific
research foundation to our focus on clinical trials, and now our
commercial expansion, we are evolving and growing. In 2009, Amarin
had fewer than twenty employees. Today, with offices in
Bridgewater, New Jersey in the United States, Dublin in Ireland,
and Zug in Switzerland, Amarin has approximately 1,000 employees
and commercial partners and suppliers around the world. We are
committed to rethinking cardiovascular risk through the advancement
of scientific understanding of the impact on society of significant
residual risk that exists beyond traditional therapies, such as
statins for cholesterol management.
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.1 The primary results of REDUCE-IT were published in The
New England Journal of Medicine in November 2018.2 The total events
results of REDUCE-IT were published in the Journal of the American
College of Cardiology in March 2019.3 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 launched in the
United States in January 2020 as the first and only drug approved
by the U.S. FDA for treatment of the studied high-risk patients
with persistent cardiovascular risk after statin therapy. 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 ten million times. VASCEPA is
covered by most major medical insurance plans. In addition to the
United States, VASCEPA is approved and sold in Canada, Lebanon and
the United Arab Emirates. In Europe, approval is anticipated in
April 2021 following the January 28, 2021 favorable opinion of the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) recommending that marketing
authorisation be granted to icosapent ethyl in the European Union
for the reduction of risk of cardiovascular events in patients at
high cardiovascular risk, under the brand name
VAZKEPA®.
Indications and Limitation of Use (in the United
States)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 = 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 U.S. FDA-APPROVED VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Forward-Looking Statements This
press release contains forward-looking statements, including
statements about expectations for further regulatory review in Hong
Kong, Mainland China and Europe and the expected timing thereof.
These forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties that may individually
or together impact the matters herein and cause actual results,
events and performance to differ materially from such forward
looking statements. Among the factors that could cause actual
results to differ materially from those described or projected
herein include the following: events that could impact future
regulatory assessment, such as delays due to COVID-19 restrictions,
later arising data or other information and uncertainties
associated generally with research and development and regulatory
submissions, reviews, action dates and anticipated approvals. 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 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;40:138-148.2 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;380:11-22.3 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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