Amarin Corporation plc (NASDAQ:AMRN) today announced the
presentation of REDUCE-IT® HEART FAILURE (HF) at ACC.21, the
American College of Cardiology’s 70th Annual Scientific Session,
being held virtually from May 15 – 17, 2021. These new analyses
supported by Amarin were presented on behalf of all authors by
Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital,
Harvard Medical School, Boston, MA.
“The REDUCE-IT HF analyses provide interesting
data about a potential new approach to addressing heart failure, a
condition that continues to challenge patients and cardiologists
worldwide,” commented Dr. Deepak L. Bhatt, M.D., M.P.H., Executive
Director of Interventional Cardiovascular Programs at Brigham and
Women’s Hospital Heart and Vascular Center, Professor of Medicine
at Harvard Medical School, and principal investigator of REDUCE-IT.
“The potential benefit of increased serum EPA levels in reducing
the composite of cardiovascular death or new heart failure
requiring hospitalization in at-risk patients is a novel finding
for icosapent ethyl and requires further prospective validation.
These results add to the growing body of knowledge regarding
icosapent ethyl.”
The REDUCE-IT HF analyses examined the effects
of icosapent ethyl on the incidence of new heart failure by
achieved on-treatment serum EPA levels in REDUCE-IT patients. New
heart failure and new heart failure requiring hospitalization were
prespecified tertiary endpoints and were not significant in the
overall patient population. Post hoc analyses were conducted based
on estimated average on-treatment EPA levels in patients in the
icosapent ethyl group with available EPA measurements, as compared
to patients in the placebo group with available EPA measurements;
these analyses showed that new heart failure and new heart failure
requiring hospitalization may be reduced in patients who achieve
serum EPA levels higher than approximately 150 µg/mL, though this
needs to be tested prospectively.
As previously reported, the REDUCE-IT
cardiovascular outcomes study enrolled 8,179 patients who were
required to be treated with statins and other conventional
therapies, and all patients had controlled low-density lipoprotein
cholesterol, elevated triglyceride levels, and either established
cardiovascular disease or diabetes with other cardiovascular risk
factors.
Heart failure is a major and often debilitating
cardiovascular condition, significantly impacting not only patients
and their loved ones, but also healthcare systems globally. In the
United States (US), the latest statistical update from the American
Heart Association (AHA) shows that approximately 6.0 million people
have HF, with the prevalence projected to increase by 46% from 2012
to 2030, affecting >8 million people 18 years of age or older.
The overall US cost of HF continues to rise as well; in 2012 the
total cost for HF was estimated to be $30.7 billion, primarily
attributable to direct medical costs. The trajectory we are on
could lead to a 127% (or $69.8 billion) increase by 2030.1
“Cardiovascular disease continues to be the
leading cause of death worldwide, with the economic and societal
burden increasing each year,” said Steven Ketchum, Ph.D., senior
vice president and president, research & development, and chief
scientific officer, Amarin. “Heart failure, in particular,
devastates patients, their families and economies with significant
direct costs and societal impact. We owe it to at-risk patients to
analyze the data from our cardiovascular outcomes study and explore
whether therapies such as icosapent ethyl might ease the
burden.”
The REDUCE-IT HF analyses include both
prespecified and post hoc analyses. Heart failure was a
prespecified tertiary endpoint within REDUCE-IT. Approximately 14%
of the patients did not have EPA levels determined at baseline;
baseline characteristics and outcomes in those with or without EPA
measures were similar. On-treatment EPA values were estimated from
available annual serum samples.
Brigham and Women’s Hospital receives research
funding from Amarin for Dr. Bhatt’s work as the REDUCE-IT study
Chair.
The REDUCE-IT HF analyses can be found here.
Additional REDUCE-IT® and icosapent ethyl (EPA)-related topics will
be presented at ACC.21 and can be found here.
Audio Webcast Information
Amarin will host an audio webcast on Monday, May
17, 2021, at 4:30 p.m. ET to further discuss these and other
VASCEPA-related findings presented during ACC.21, with replay
available for a period of 14 days. The discussion will include
various clinicians and scientists and will be moderated by Amarin’s
chief medical officer, Craig Granowitz, M.D., Ph.D. To listen
please register here, listen live on the investor relations section
of the company's website at www.amarincorp.com, or via telephone by
dialing 877-545-0320 within the United States, 973-528-0016 from
outside the United States. A replay of the call will be made
available for a period of two weeks following the conference call.
To hear a replay of the call, dial 877-481-4010 within the United
States, 919-882-2331, PIN: 41266. Any opinions or views expressed
by the clinicians and scientists on the audio webcast are theirs
alone. They have neither been scripted nor previewed by Amarin.
While Amarin respects the scientific opinions of these clinicians
and scientists, Amarin takes no responsibility for those opinions.
Rather, this audio webcast is intended to provide summaries of
recently presented scientific data for consideration by Amarin’s
investors.
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 Risk
Cardiovascular 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.2 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%.3 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.
4,5,6
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 2018.8 The total events
results of REDUCE-IT were published in the Journal of the American
College of Cardiology in March 2019.9 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)
Capsules
VASCEPA (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 (%) |
IncidenceRate (per
100patientyears) |
N = 4090n (%) |
IncidenceRate (per
100patientyears) |
Hazard Ratio(95% CI) |
Primary composite endpoint |
Cardiovascular death, myocardial infarction, stroke,
coronary revascularization, hospitalization forunstable 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, myocardiali nfarction, 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 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
Amarin
Investors 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) 719-1315IR@amarincorp.com
(investor inquiries)
Solebury Troutamarinir@troutgroup.com
Media Inquiries:CommunicationsAmarin Corporation
plcIn U.S.: +1 (908) 892-2028PR@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.
1 American Heart Association. Heart Disease and
Stroke Statistics—2021 Update: A Report From the American Heart
Association. Circulation. 2021;143:e254–e743.2 American Heart
Association. Heart Disease and Stroke Statistics—2020 Update: A
Report From the American Heart Association. Circulation.
2020;141:e139-e596.3 Ganda OP, Bhatt DL, Mason RP, et al. Unmet
need for adjunctive dyslipidemia therapy in hypertriglyceridemia
management. J Am Coll Cardiol. 2018;72(3):330-343.4 Budoff M.
Triglycerides and triglyceride-rich lipoproteins in the causal
pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
5 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):e008740.6 Nordestgaard BG.
Triglyceride-rich lipoproteins and atherosclerotic cardiovascular
disease - New insights from epidemiology, genetics, and biology.
Circ Res. 2016;118:547-563.7 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;40:138-148.8 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;380:11-22.9 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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