Amarin Corporation plc (NASDAQ: AMRN) today announced that the
Canadian Cardiovascular Society (CCS) and the Egyptian Heart
Journal (EHJ) (the official journal of the Egyptian Cardiovascular
Society) have included icosapent ethyl in the 2021 Canadian
Cardiovascular Society Guidelines1 and in the Egyptian Heart
Journal’s Practical Guidance in Lipid Management2 respectively, for
the reduction of cardiovascular risk. These recommendations
increase to 15 the number of global organizations or medical
societies that recommend icosapent ethyl for cardiovascular risk
reduction following its previously reported favorable outcomes
study results. These independent recommendations support the
company’s view that this important drug, marketed in the United
States as VASCEPA®, is rapidly becoming a new standard of care for
the treatment of appropriate high-risk patients.
The CCS guideline recommends, “the use of
icosapent ethyl to lower the risk of CV events in patients with
atherosclerotic cardiovascular disease (ASCVD), or with diabetes
and ≥1 CVD risk factors, who have an elevated fasting triglyceride
level of 1.5-5.6 mmol/L despite treatment with maximally tolerated
statin therapy”. Further, CCS guideline authors, “do not recommend
the use of over-the-counter omega-3 polyunsaturated fatty acids
supplements (marketed as natural health products in Canada) to
reduce CVD risk”.1 The reference to over-the-counter is understood
in other parts of the world to refer to dietary supplements.
The Egyptian Heart Journal practical guidance in
lipid management lists icosapent ethyl as a consideration in
patients with high triglyceride (HTG) levels (above 200 mg/dL). The
recommendation excludes secondary causes of HTG [TG levels > 200
mg/dL] as part of patient management and advises to treat them
separately. Patients with HTG and at high risk must receive a
statin as a first-line treatment to reduce cardiovascular disease
(CVD) risk. In high-risk (or above) patients with TG levels between
135 and 499 mg/dL despite statin treatment, n-3 PUFAs (icosapent
ethyl 2 × 2g/day) should be considered in combination with a
statin.2
“Inclusion in these new guidelines underscores
the growing global acceptance of the clinical benefits of pure
icosapent ethyl in reducing cardiovascular risk as supported by the
landmark REDUCE-IT® study of VASCEPA and further validates the
independent support of this unique agent by the scientific
community,” stated Craig B. Granowitz, M.D., Ph.D., senior vice
president and chief medical officer of Amarin. “With these new
recommendations, icosapent ethyl is now included in the treatment
guidelines or otherwise recommended for use by 15 medical
associations internationally, further validating icosapent ethyl as
an important treatment option beyond cholesterol management for
millions of patients worldwide at risk for a cardiovascular
event.”
The recommendation from the CCS was classified
as ‘Strong Recommendation; High-Quality Evidence’ and supported by
the results of the REDUCE-IT cardiovascular outcomes study. The
results of REDUCE-IT cannot be extrapolated to other
non-prescription omega-3 fatty acids.
The CCS and the EHJ do not provide endorsements
of any brand name commercial product. Accordingly, the CCS “2021
Canadian Cardiovascular Society Guidelines for the Management of
Dyslipidemia for the Prevention of Cardiovascular Disease in the
Adult” and the EHJ “Egyptian Practical Guidance in Lipid
Management” reference icosapent ethyl. The guidelines do not
reference VASCEPA, the brand name of icosapent ethyl in the United
States, and such guidelines should not be construed as an
endorsement or approval of VASCEPA by the CCS or EHJ.
Amarin acknowledges the rigor with which these
documents are developed and approved by the CCS and the EHJ, which
are comprised of leading medical professionals in Canada and Egypt
who specialize in the care of patients with CVD.
The complete “2021 Canadian Cardiovascular
Society Guidelines for the Management of Dyslipidemia for the
Prevention of Cardiovascular Disease in the Adult” addressing
Primary and Secondary Prevention of Cardiovascular Diseases with
icosapent ethyl published in the Canadian Journal of Cardiology can
be accessed online here. The “Egyptian Practical Guidance in Lipid
Management” as published in The Egyptian Heart Journal can be
accessed online here.
Information on other medical societies that
include icosapent ethyl in their guidelines can be accessed
here.
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 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.3 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%.4 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.5,6,7
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.8 The primary results of REDUCE-IT were published
in The New England Journal of Medicine in November 2018.9 The
total events results of REDUCE-IT were published in the Journal of
the American College of Cardiology in March 2019.10 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 |
VASCEPAvs Placebo |
N =4089n (%) |
IncidenceRate (per
100patientyears) |
N = 4090n (%) |
IncidenceRate (per
100patientyears) |
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 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 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. 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 RelationsIn U.S.:
+1 (908) 719-1315Amarin Corporation plcIR@amarincorp.com (investor
inquiries)
Solebury Troutlstern@soleburytrout.com
Media Inquiries:Alina
KolomeyerCommunicationsAmarin Corporation plcIn U.S.: +1 (908)
892-2028 PR@amarincorp.com (media inquiries)
1 |
Pearson GJ, et al. 2021 Canadian
Cardiovascular Society Guidelines for the Management of
Dyslipidemia for the Prevention of Cardiovascular Disease in the
Adult. Can J Cardiol. 2021, Article in Press. DOI:
https://doi.org/10.1016/j.cjca.2021.03.016 Epub 2021 March 26. |
2 |
Taha HSED, et al. Egyptian
practical guidance in lipid management 2020. Egypt Heart J.
2021;73(1):17. doi: 10.1186/s43044-021-00140-1. |
3 |
American Heart Association. Heart
Disease and Stroke Statistics—2020 Update: A Report From the
American Heart Association. Circulation.
2020;141:e139–e596. |
4 |
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. |
5 |
Budoff M. Triglycerides and
triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol. 2016;118:138-145. |
6 |
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. |
7 |
Nordestgaard BG.
Triglyceride-rich lipoproteins and atherosclerotic cardiovascular
disease - New insights from epidemiology, genetics, and biology.
Circ Res. 2016;118:547-563. |
8 |
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. |
9 |
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. |
10 |
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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