Amarin Corporation plc (NASDAQ:AMRN) today announced the
presentation of REDUCE-IT® STROKE at the International Stroke
Conference 2021, being held virtually from March 17 – March 19,
2021, adding to the growing body of knowledge on the clinical
impact of VASCEPA® (icosapent ethyl). 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 STROKE analyses provide important
data supporting a new approach to prevent strokes using icosapent
ethyl in appropriate patients,” commented Dr. Deepak L. Bhatt,
M.D., M.P.H., Executive Director of Interventional Cardiovascular
Programs at Brigham and Women’s Hospital, Professor of Medicine at
Harvard Medical School, and principal investigator of REDUCE-IT.
“The findings of benefit in at-risk patients include significant
reductions in overall strokes and in ischemic strokes. Importantly,
with respect to safety, we did not observe any significant increase
in hemorrhagic stroke. These results further strengthen the case
for pure eicosapentaenoic acid (EPA) in the form of prescription
icosapent ethyl as a key intervention beyond statins for stroke
prevention in studied patients.”
The REDUCE-IT STROKE analyses examined stroke
rates across the enrolled patient population (n=8179). Enrolled
patients were required to be treated with statins and other
conventional therapies, and all patients had either established
cardiovascular disease or diabetes and had other cardiovascular
risk factors such as elevated triglyceride levels. Event rates for
time to first fatal or nonfatal stroke were 2.4% for VASCEPA vs.
3.3% for placebo for a relative risk reduction (RRR) of 28%
(p=0.01). Ischemic stroke time to first event rates were 2.0% for
VASCEPA vs. 3.0% for placebo for a RRR of 36% (p=0.002).
Hemorrhagic stroke occurred at low rates with no significant
difference for VASCEPA vs. placebo (0.3% vs 0.2%; p=0.55).
Stroke is a major and often debilitating
cardiovascular event significantly impacting not only patients and
their loved ones, but also the healthcare system. Patients with
elevated triglycerides despite statin therapy have increased risk
for stroke-related events. Each year in the United States, about
795,000 people experience a new or recurrent stroke. Approximately
610,000 of these are first strokes, and 185,000 are recurrent
strokes, or approximately 1 stroke every 40 seconds.1 The latest
statistical update from the American Heart Association (AHA) shows
that in the United States, the annual cost of stroke is $49.8
Billion.2
“Strokes significantly impact the healthcare
system, driving substantial immediate and long-term costs,” said
Steven Ketchum, Ph.D., senior vice president and president,
research & development and chief scientific officer, Amarin.
“The subgroup data presented at ISC 2021 provide new insight into
the unique potential benefits of VASCEPA administration on
alleviating the societal burden of strokes.”
The REDUCE-IT STROKE abstract received the
prestigious Paul Dudley White International Scholar Award,
recognizing the authors with the highest ranked abstract across the
United States at the International Stroke Conference 2021. The
esteemed Paul Dudley White Award is named in honor of one of
Boston’s most revered cardiologists, Dr. Paul Dudley White, who was
a founding father of the American Heart Association and an early
leader in preventive cardiology.
REDUCE-IT was designed and powered for the
primary composite endpoint, of which stroke was one of five
prespecified components; it was not powered for subgroup analysis.
Stroke was a prespecified secondary endpoint within the testing
hierarchy; ischemic stroke was a prespecified tertiary endpoint;
stroke subgroup analyses were post hoc. No information was
collected on stroke related disability, such as Rankin scores.
Brigham and Women’s Hospital receives research
funding from Amarin for Dr. Bhatt’s work as the REDUCE-IT study
Chair.
Additional information on ISC 2021 can be found
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.1 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%.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)
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 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 American Heart Association. Heart Disease and Stroke
Statistics—2020 Update: A Report From the American Heart
Association. Circulation. 2020;141:e139–e596.2 American Heart
Association. Heart Disease and Stroke Statistics—2021 Update: A
Report From the American Heart Association. Circulation.
2021;143:e254–e743.3 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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