Research Presented at the American Heart Association’s Quality of Care and Outcomes Research (QCOR) Scientific Sessions Indicate Potential for VASCEPA® (icosapent ethyl) to Reduce Major Adverse Cardiovascular (CV) Events and Associated Costs
May 16 2022 - 8:00AM
Amarin Corporation plc (NASDAQ:AMRN) today announced that research
on the potential population health impact and cost-effectiveness of
VASCEPA® (icosapent ethyl), presented in two poster presentations
at the American Heart Association’s Quality of Care and Outcomes
Research Scientific Sessions in Reston, VA, May 13-14, 2022,
showcased significant potential to reduce major cardiovascular (CV)
events and associated costs.
The posters explored the potential for icosapent ethyl to
prevent atherosclerotic cardiovascular disease-related events and
associated costs among 3.6 million1 patients estimated to be
eligible for treatment according to REDUCE-IT® trial criteria, and
cost-effectiveness of treatment with icosapent ethyl among
appropriate adult patients in the United States.
Amarin-supported abstracts to be presented at
#QCOR22 included:
- Presentation
Title: The Potential Population Health Impact of
Treating US Adults with Icosapent Ethyl; Abstract ID#: 244; C.G.
Derington, et al, presented on behalf of all authors by Catherine
G. Derington, PharmD, MS, University of Utah, Salt Lake City, UT.
Publication in the American Journal of Preventive Cardiology. 1Key
Conclusions: If the estimated 3.6 million REDUCE-IT eligible US
adults were treated for one year with IPE, 50,000 first and 97,000
total ASCVD events could be prevented. Annually, $3.4 billion from
preventing 97,000 total events (first and recurrent) could be
saved, resulting in a net burden of $2.6 billion. Annual indirect
($21.6 billion) and outpatient ($23.5 billion) costs in this
population are high. If a small proportion (e.g., 5%) of outpatient
and indirect costs are prevented with one year of treatment, then
IPE is a cost-saving therapy.
- Presentation Title: Cost-Effectiveness of
Icosapent Ethyl in Reduce-IT USA: Results from Patients Randomized
In The United States; Abstract ID# 170; Z. Zhang, et al, presented
on behalf of all authors by Zugui Zhang, PhD, Christiana Care
Health System, Newark, DEKey Conclusions: The REDUCE-IT USA
cost-effectiveness analysis has shown that IPE provides better
outcomes with lower costs, dominant both in-trial and lifetime as
well as in the majority of sensitivity analyses and subgroups, both
in primary and secondary prevention. These results, with the
clinical evidence of efficacy, suggest that at $4.16 per day, IE
therapy should be strongly considered in patients similar to those
enrolled in REDUCE-IT USA.
“The AHA has been a powerful voice in calling attention to the
increasing health and economic burden on patients and our health
systems from inadequately prioritizing and addressing heart disease
and related risks,” said Karim Mikhail, Amarin’s president and
chief executive officer. “The analyses presented at QCOR reinforce
that icosapent ethyl, if prescribed and used consistently to treat
eligible patients, can and should be an important tool in helping
to reduce the staggering impacts and costs of cardiovascular
disease in the U.S.”
_______________1 Derington CG, Bress AP, Herrick JS, Fan W, Wong
ND, Andrade KE, Johnson J, Philip S, Abrahamson D, Jiao L, Bhatt
DL, Weintraub WS. The Potential Population Health Impact of
Treating REDUCE-IT eligible US adults with Icosapent Ethyl. Am J
Prev Cardiol 2022 [E-pub ahead of print].
https://doi.org/10.1016/j.ajpc.2022.100345.
About Amarin Amarin is an innovative
pharmaceutical company leading a new paradigm in cardiovascular
disease management. From our foundation in scientific research 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,
Zug in Switzerland, and other countries in Europe as well as
commercial partners and suppliers around the world. We are
committed to increasing the scientific understanding of the
cardiovascular risk that persists beyond traditional therapies and
advancing the treatment of that risk.
About VASCEPA® (icosapent ethyl)
CapsulesVASCEPA (icosapent ethyl) capsules are the first
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 drug approved by the U.S. FDA for treatment of the studied
high-risk patients with persistent cardiovascular risk despite
being on 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
more than 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, Germany, 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.
FULL U.S. FDA-APPROVED VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Forward-Looking StatementsThis press release
contains forward-looking statements which are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, including beliefs about the potential for VASCEPA
(marketed as VAZKEPA in Europe); beliefs about icosapent ethyl
(IPE)’s role concerning appropriate patients suffering from
cardiovascular disease (CVD) and potential population health impact
and economics and cost, as well as general beliefs about the safety
and effectiveness of VASCEPA. These forward-looking statements are
not promises or guarantees and involve substantial risks and
uncertainties. 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 Amarin’s annual report on Form
10-K for the full year ended 2021. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date they
are made. Amarin undertakes no obligation to update or revise the
information contained in its forward-looking statements, 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
communicates with its investors and the public using the company
website (www.amarincorp.com) and the investor relations website
(investor.amarincorp.com), including but not limited to investor
presentations and 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 Information Investor Inquiries:
Investor Relations Amarin Corporation plc In U.S.: +1 (908)
719-1315 IR@amarincorp.com (investor inquiries)
Media Inquiries: Communications Amarin Corporation plc In U.S.:
+1 (908) 892-2028 PR@amarincorp.com (media inquiries)
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