Amarin Corporation plc (NASDAQ:AMRN) today announced the
first presentation of REDUCE-IT® RENAL results at American Society
of Nephrology (ASN) Kidney Week 2020, held virtually from October
22 – October 25. REDUCE-IT RENAL consisted of important
prespecified and post hoc subgroup analyses of patients from the
landmark REDUCE-IT cardiovascular outcomes study who had
compromised renal function. The results of these analyses add to
the growing body of knowledge on the clinical impact of VASCEPA®
(icosapent ethyl) in at-risk patient populations. These new
analyses, supported by Amarin, were presented by Arjun Majithia,
M.D., Lahey Clinic.
“In the REDUCE-IT RENAL analyses we not only
studied outcomes following icosapent ethyl administration, which
were greatly improved, but equally importantly, we also examined
the event rates in at-risk patients with compromised renal
function, which clearly demonstrate that those patients urgently
need additional solutions for cardiovascular risk reduction,”
commented Dr. Deepak L. Bhatt, M.D., M.P.H., Executive Director of
Interventional Cardiovascular Programs at Brigham and Women’s
Hospital and Professor of Medicine at Harvard Medical School,
principal investigator of REDUCE-IT and senior author of the
REDUCE-IT RENAL analyses.
The REDUCE-IT RENAL analyses examined the full
REDUCE-IT cardiovascular outcomes study patient population in
prespecified and post hoc analyses across subgroups of eGFR
categories. The primary endpoint (5-point major adverse
cardiovascular events [MACE] consisting of non-fatal myocardial
infarction [MI], stroke, cardiovascular death, unstable angina
requiring hospitalization and coronary revascularization) and key
secondary endpoint (3-point MACE consisting of non-fatal MI, stroke
and cardiovascular death) events were consistently reduced when
looking at data cut by prespecified baseline eGFR categories; eGFR
<60 mL/min/1.73 m2 (n=1816), eGFR ≥60 to <90 mL/min/1.73 m²
(n=4455), and eGFR ≥90 mL/min/1.73 m² (n=1902). Similar consistent
cardiovascular risk reduction benefits were observed across post
hoc analyses by finer cuts of eGFR categories. Primary and key
secondary endpoint MACE rates increased with decreasing eGFR
compared to the total patient population studied in REDUCE-IT,
resulting in similarly favorable relative risk reductions and
numerically greater absolute risk reductions with VASCEPA versus
placebo in comparison with the overall patient population.
Adverse event rates were higher with decreasing
eGFR, but total adverse events occurred at similar rates with
VASCEPA versus placebo. A safety profile similar to the full
REDUCE-IT study cohort was observed for VASCEPA compared with
placebo across eGFR subgroups.
“We continue to see the consistency in benefit
and safety of VASCEPA administration across various at-risk patient
populations, including across varying degrees of renal function,”
said Steven Ketchum, Ph.D., senior vice president and president,
research & development and chief scientific officer, Amarin.
“It is notable that, despite observing with REDUCE-IT patients the
known increase in cardiovascular events with decreased kidney
function, all patients experienced similar relative cardiovascular
risk reduction benefits, resulting in overall greater absolute risk
reductions in patients with compromised kidney function.”
“It is important to provide cardiovascular risk
reduction solutions for patients with chronic kidney disease as
data continue to highlight cardiovascular disease as an unfortunate
and damaging comorbidity,” added Craig Granowitz, M.D., Ph.D.,
Amarin’s senior vice president and chief medical officer.
REDUCE-IT was not specifically powered to
examine individual cardiovascular endpoints or patient subgroups,
and urine samples were not collected during the REDUCE-IT
study.
In addition to presentation of REDUCE-IT RENAL
at ASN Kidney Week 2020, as previously reported, a separate
presentation was made of real-world data analysis of U.S. veterans
showing that increased triglyceride levels in patients with
compromised renal function is a potential predictor of increased
risk of cardiovascular events.
Links to above cited
data presented at ASN Kidney Week
2020
“Benefits of Icosapent Ethyl Across a Range of
Baseline Renal Function in Patients with Established Cardiovascular
Disease or Diabetes: Results of REDUCE-IT RENAL” – presented on
behalf of all authors by Arjun Majithia, M.D. – available from
October 23
“Increased Residual Cardiovascular Risk in US
Veterans with Moderately Elevated Baseline Triglycerides,
Well-Controlled LDL Cholesterol Levels on Statins, and Decreased
Renal Function” – presented on behalf of all authors by Sarah
Leatherman, Ph.D. – available from October 22
Additional information on ASN Kidney Week 2020
can be found here.
About Amarin Amarin Corporation
plc is a rapidly growing, innovative pharmaceutical company focused
on developing and commercializing therapeutics to cost-effectively
improve cardiovascular health. Amarin’s lead product, VASCEPA®
(icosapent ethyl), is available by prescription in the United
States, Canada, Lebanon and the United Arab Emirates. VASCEPA is
not yet approved and available in any other countries. Amarin, on
its own or together with its commercial partners in select
geographies, is pursuing additional regulatory approvals for
VASCEPA in China, Europe and the Middle East. For more information
about Amarin, visit www.amarincorp.com.
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%.2 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.3,4,5
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.6 The primary results of REDUCE-IT were published in The
New England Journal of Medicine in November 2018.7 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 FDA comprised
solely of the active ingredient, icosapent ethyl (IPE), a unique
form of eicosapentaenoic acid. 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 eight million times. VASCEPA is covered by most major medical
insurance plans. The new, cardiovascular risk indication for
VASCEPA was approved by the FDA in December 2019.
Indications and Limitation of UseVASCEPA 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 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
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:Elisabeth SchwartzInvestor
RelationsAmarin Corporation plcIn U.S.: +1 (908) 719-1315
IR@amarincorp.com (investor inquiries)
Lee M. SternSolebury TroutIn U.S.: +1 (646)
378-2992 lstern@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 Ganda OP, Bhatt
DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy
in hypertriglyceridemia management. J Am Coll Cardiol.
2018;72(3):330-343.3 Budoff M. Triglycerides and
triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol. 2016;118:138-145.4 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):e008740.5 Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.6 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;40:138-148.7 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;380:11-22.8 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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