Amarin Corporation plc (NASDAQ: AMRN) today announced that the
Medicines and Healthcare Products Regulatory Agency (MHRA) has
granted a Marketing Authorization for VAZKEPA (icosapent ethyl) as
a treatment to reduce the risk of cardiovascular events in high
cardiovascular 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. The Great Britain Marketing
Authorization for VAZKEPA applies to England, Scotland and Wales.
Under the Brexit Northern Ireland agreement, the European
centralized marketing authorization for the European Union covers
Northern Ireland.
The MHRA’s license swiftly followed the European
Commission (EC) marketing authorization of icosapent ethyl for the
European Union as announced on March 30, 2021.3 Amarin’s
understanding is that icosapent ethyl is among the first products
to be submitted and licensed through the MHRA’s new ‘reliance’
route following the end of the Brexit transition period. Icosapent
ethyl has been identified as a new active substance with likely
multi-factorial mechanisms of action.1
The MHRA authorization 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.
Professor Gabriel Steg, M.D., Chief, Department
of Cardiology at Hôpital Bichat, Paris, commented, “The REDUCE-IT
study shows icosapent ethyl could reduce CV events and has the
potential to change the way residual cardiovascular risk is
treated. This authorization of icosapent ethyl can make a
difference to patients who are at high-risk of suffering from a
heart attack or stroke. Eligible patients can be confident we have
a new treatment that is backed by evidence-based data and European
guideline recommendations.”
The publication of this research has led to
icosapent ethyl being recommended for use in high-risk
statin-treated patients identified by moderately elevated
triglycerides by 15 global medical societies around the world
including the European Society of Cardiology and the European
Atherosclerosis Society.4
Cardiovascular risk (CVD) is one of the leading
causes of death in the United Kingdom, with heart and circulatory
diseases causing more than a quarter (27%) of all deaths in the UK,
which is more than 160,000 deaths each year.5
The marketing authorization is also timely in
the wake of the COVID-19 pandemic, which has resulted in the
reprioritization of clinical resources, often leaving patients with
serious cardiovascular disease to delay much needed medical help.6
Preventative care is needed for at-risk patients with
cardiovascular disease, including LDL-cholesterol management and
additional treatments for statin-treated patients with residual
cardiovascular risk, identified by elevated triglycerides and other
risk factors, to address their unmet need.
“Icosapent ethyl has been helping to reduce
strokes, heart attacks and other major cardiovascular events in
high-risk patients in the United States,” stated John Thero,
president and chief executive officer of Amarin. “We are dedicated
to the rethinking of cardiovascular disease risk reduction across
Europe with an emphasis on preventative care. Amarin will work
tirelessly throughout Europe to make icosapent ethyl available to
all patients who may benefit from this important therapy.”
In addition, the company announced that
subsequent to the marketing authorization by the EC, the Norwegian
Medicines Agency informed Amarin of its marketing authorization for
VAZKEPA in Norway.
Information regarding Amarin’s plans for
commercialization and securing market access in Europe and the
United Kingdom can be found in the FAQ section under investor
relations at www.amarincorp.com.
About Amarin Amarin is an
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 rapidly. Amarin has
offices in Bridgewater, New Jersey in the United
States, Dublin in Ireland, and Zug in Switzerland as well as
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 Cardiovascular RiskCardiovascular disease
is the number one cause of death in the world. In the United States
alone, cardiovascular disease results in 859,000 deaths per year.7
And the number of deaths in the United States attributed to
cardiovascular disease continues to rise. In addition, in the
United States there are 605,000 new and 200,000 recurrent heart
attacks per year (approximately 1 every 40 seconds). Stroke rates
are 795,000 per year (approximately 1 every 40 seconds), accounting
for 1 of every 19 U.S. deaths. In aggregate, in the United States
alone, there are more than 2.4 million major adverse cardiovascular
events per year from cardiovascular disease or, on average, 1 every
13 seconds.
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%.8 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.9,10,11
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 2018.2
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 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, in March 2021 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, myocardialinfarction, 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 and about making VAZKEPA available throughout
Europe to patients who are at risk of a cardiovascular event. 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, 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)
AMARIN, REDUCE-IT, 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.
1Summary of Product Characteristics Vazkepa – April 2021
https://ec.europa.eu/health/documents/community-register/2021/20210326150935/anx_150935_en.pdf 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 Union Register of medicinal products - Public
health - European Commission.
https://ec.europa.eu/health/documents/community-register/html/h1524.htm.
Accessed April 22, 2021.4 2019 ESC/EAS guidelines for the
management of dyslipidaemias: Lipid modification to reduce
cardiovascular risk. Atherosclerosis. 2019;290:140-205.5
BHF/University of Birmingham calculated rates in partnership with
UK statistical agencies: ONS/NRS/NISRA (2016-18 data)6 Fersia O,
Bryant S, Nicholson R, et al. The impact of the COVID-19 pandemic
on cardiology services. Heart. 2020;7:1359.7 American Heart
Association. Heart Disease and Stroke Statistics—2020 Update: A
Report From the American Heart Association. Circulation.
2020;141:e139–e596.8 Ganda OP, Bhatt DL, Mason RP, et al. Unmet
need for adjunctive dyslipidemia therapy in hypertriglyceridemia
management. J Am Coll Cardiol. 2018;72(3):330-343.9 Budoff M.
Triglycerides and triglyceride-rich lipoproteins in the causal
pathway of cardiovascular disease. Am J Cardiol.
2016;118:138-145.10 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):e008740.11
Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic
cardiovascular disease - New insights from epidemiology, genetics,
and biology. Circ Res. 2016;118:547-563.12 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;40:138-148.13 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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