Amarin Corporation plc (NASDAQ: AMRN) today announced that
following a review and approval recommendation by the European
Medicines Agency (EMA), the European Commission (EC) has approved
the marketing authorization application for VAZKEPA (icosapent
ethyl) to reduce the risk of cardiovascular events in high-risk,
statin-treated adult patients who have elevated triglycerides (≥150
mg/dL) and either established cardiovascular disease or diabetes
and at least one additional cardiovascular risk factor.
Amarin’s icosapent ethyl was approved for
cardiovascular risk reduction by the U.S. Food and Drug
Administration (FDA) in December 2019 and is marketed in the U.S.
under the brand name, VASCEPA®.
“The approval of VAZKEPA marks a significant
milestone for high-risk cardiovascular patients in Europe as it
offers the first and only EC-approved therapy to reduce
cardiovascular risk in high-risk statin-treated patients who have
elevated triglycerides,” said Steven Ketchum, senior vice
president, president of R&D and chief scientific officer of
Amarin. “We look forward to launching VAZKEPA in Europe as it is an
exciting opportunity for Amarin to make a difference in the lives
of the many millions of patients throughout Europe who are at risk
of a cardiovascular event.”
The EC approval for VAZKEPA is based on over a
decade of development and testing of icosapent ethyl, including
efficacy and safety data from the REDUCE-IT® cardiovascular
outcomes study.2 REDUCE-IT evaluated more than 8,000 high risk
patients who despite having their cholesterol levels well
controlled by statin therapy remained at significant risk of heart
attack, stroke, or other major adverse cardiovascular events
(MACE), including death. As published, patients in the REDUCE-IT
study had a median follow-up period of nearly five years. Results
from this study, in which all patients remained treated with
statins (and with other contemporary therapies) and where half the
patients received icosapent ethyl and the other half received
placebo, demonstrated a 25% relative risk reduction (p<0.001) in
the first occurrence of MACE in the intent-to-treat patient
population with use of icosapent ethyl (4 grams daily) compared
with placebo.
“We are especially pleased to receive the EC’s
approval of VAZKEPA to reduce cardiovascular risk as cardiovascular
disease remains the number one cause of death in the European Union
and its economic burden exceeds €210 billion per year3,” stated
John F. Thero, president and chief executive officer. “We believe
we are well positioned for a successful launch based on the high
rate of cardiovascular events in Europe, the lack of an approved
therapy for the indication VAZKEPA is positioned to address, and
because of the demonstrated efficacy and safety profile of this
unique drug.”
“Importantly, this EC approval provides ten
years of market protection for VAZKEPA in the European Union. In
addition, we have pending patent applications related to the
REDUCE-IT study, which have the potential to extend exclusivity in
Europe into 2039,” added Mr. Thero.
In anticipation of the
commercial availability of VAZKEPA in
Europe, the European Society of
Cardiology and European Atherosclerosis
Society updated its 2019 Dyslipidemia Management
Guidelines to recommend the use of icosapent ethyl in
high-risk, statin-treated patients.4 Globally, there are 15 medical
societies that recommend the use of icosapent ethyl in appropriate
patients, emphasizing that the positive clinical results of the
REDUCE-IT cardiovascular outcomes study should not be generalized
to any product other than icosapent ethyl, and noting that the
clinical results are unique to VASCEPA/VAZKEPA.
Information regarding Amarin’s plans for
commercialization and securing market access in Europe can be found
in the FAQ section under investor relations at
www.amarincorp.com.
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.5 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 2019.6 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. Food and
Drug Administration (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, marketing authorization was 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 the potential of VAZKEPA (known as VASCEPA in the
United States) to favorably affect cardiovascular risk in
appropriate patients, to make a difference in the lives of the many
millions of patients throughout Europe who are at risk of a
cardiovascular event, with respect to Amarin being well-positioned
for a successful European launch and related to the potential for
extended patent protection. 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 by the European
Commission, such as delays due to COVID-19 restrictions, later
arising data, regulatory reviews and pricing assessments, and the
successful implementation of commercialization plans or other
information, events that could interfere with the grant or issuance
of a patent, continued validity or enforceability of a patent;
uncertainties associated with litigation generally and patent
litigation specifically; Amarin's ability generally to maintain
adequate patent protection and successfully enforce patent claims
against third parties; and uncertainties associated generally with
research and development and regulatory submissions, reviews,
action dates and 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 annual report on
Form 10-K. 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.
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:CommunicationsAmarin Corporation
plcIn U.S.: +1 (908) 892-2028 PR@amarincorp.com (media
inquiries)
____________________________
1 Union Register of medicinal products - Public health -
European Commission.
https://ec.europa.eu/health/documents/community-register/html/h1524.htm.
Accessed March 30, 2021.2 Bhatt DL, Steg PG, Miller M, et al.
Cardiovascular Risk Reduction with Icosapent Ethyl for
Hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22.3 ESC
Cardiovascular Realities 2020 by... - Flipsnack.
https://www.flipsnack.com/Escardio/esc-cardiovascular-realities-2020/full-view.html.
Accessed March 30, 2021. 4 Mach F, Baigent C, Catapano AL, et
al. 2019 ESC/EAS guidelines for the management of dyslipidaemias:
Lipid modification to reduce cardiovascular
risk. Atherosclerosis. 2019;290:140-205.
doi:10.1016/j.atherosclerosis.2019.08.014 5 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;40:138-148.6 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.
VASCEPA and VAZKEPA are trademarks of Amarin Pharmaceuticals
Ireland Limited. VAZKEPA is a registered trademark in Europe and
other countries and regions and is pending registration in the
United States.
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