Amarin Corporation plc (NASDAQ: AMRN) today announced that the
Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of
the U.S. Food and Drug Administration (FDA) has voted unanimously
(16-0) to recommend approval of an indication and label expansion
for Vascepa® (icosapent ethyl) capsules to reduce the risk of
cardiovascular events in high-risk patients based on results from
the landmark REDUCE-IT®1 cardiovascular outcomes trial.
The FDA is not bound by the recommendations of an advisory
committee. Amarin plans to work with the agency as it completes its
review of the company’s application seeking an appropriate label
expansion for Vascepa to reflect REDUCE-IT results.
Cardiovascular disease is the number one cause of death for men
and women in the United States and the nation’s costliest disease,
with direct and indirect expenses in excess of $500 billion each
year.2 An independent drug pricing watchdog group concluded that
Vascepa is cost effective for cardiovascular risk reduction as
demonstrated in REDUCE-IT even under the most stringent standards
of that group, a result rarely achieved in its
analyses.3
“Today we moved an important step closer to potentially helping
millions of patients who are at risk for cardiovascular events
despite being on standard-of-care statin therapy,” said John F.
Thero, president and chief executive officer of Amarin. “Vascepa is
positioned to be the first approved treatment to reduce
cardiovascular events in the group of at-risk patients studied in
the landmark REDUCE-IT clinical trial. We appreciate both the
opportunity to present these results and the committee’s strong
vote of confidence. We look forward to anticipated labeling
discussions with the FDA, and we continue to prepare for the launch
of Vascepa assuming FDA approval of our sNDA on or before the
target PDUFA date of December 28.”
Deepak L. Bhatt, M.D., M.P.H., executive director of
Interventional Cardiovascular Programs at Brigham and Women’s
Hospital Heart and Vascular Center, and professor of medicine at
Harvard Medical School, said: “The REDUCE-IT results are quite
remarkable and illustrate how icosapent ethyl could transform the
treatment of cardiovascular disease in the United States and
worldwide. From my perspective as not only a researcher but also a
practicing physician, icosapent ethyl represents one of the most
important developments in the prevention and treatment of
cardiovascular disease since statins and, if FDA approved, will be
a critical tool for physicians to use to help prevent
cardiovascular events such as heart attack and stroke, including
fatal ones, in high-risk patients.”
“Amarin thanks the patients, advocacy groups, physicians,
researchers, and others who expressed overwhelming support for
Vascepa through their written and in person comments at the
advisory committee meeting,” Thero said. “We also recognize the
contributions of the 8,179 patients who participated in REDUCE-IT,
some for over six years. Thousands of patients and professionals
contributed to the REDUCE-IT results. We look forward to having
their sacrifices and contributions reflected in an expanded
indication for Vascepa that has the potential to benefit millions
of patients.”
About REDUCE-IT®REDUCE-IT was a global
cardiovascular outcomes study designed to prospectively 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). The
REDUCE-IT®4 cardiovascular outcomes trial study was conducted
over seven years, completed in 2018, and 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 Cardiology4 and can be found in the R&D
section on the company’s website at www.amarincorp.com. The
primary results of REDUCE-IT were published in The New England
Journal of Medicine in November 2018.5
About Cardiovascular RiskThe number of deaths
in the United States attributed to cardiovascular disease continues
to rise.6,7 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 similar, accounting for 1 of every 19 U.S.
deaths (approximately 1 every 40 seconds).8
Controlling bad cholesterol, also known as LDL-C, is one way to
reduce a patient’s risk for cardiovascular events. 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 high triglycerides, a type
of fat in the blood. Statin therapy has been shown to control
LDL-C, thereby reducing the risk of cardiovascular events by 25-35%
– but that still leaves a 65-75% risk remaining.9 People with high
triglycerides have 35% more cardiovascular events compared to
people with normal (in range) triglycerides taking
stains.10,11,12,13
About VASCEPA® (icosapent ethyl)
CapsulesVascepa (icosapent ethyl) capsules are a
single-molecule prescription product consisting of the omega-3 acid
commonly known as EPA in ethyl-ester form (known as icosapent ethyl
or IPE). Vascepa is not fish oil, but is derived from fish through
a stringent and complex FDA-regulated manufacturing process
designed to effectively eliminate impurities and isolate and
protect the single molecule active ingredient from degradation.
Vascepa, known in scientific literature as AMR101, has been
designated a new chemical entity by the FDA. Amarin has been issued
multiple patents internationally based on the unique clinical
profile of Vascepa, including the drug’s ability to lower
triglyceride levels in relevant patient populations without raising
LDL-cholesterol levels.
The FDA has not reviewed the information herein or determined
whether to approve Vascepa for use to reduce the risk of major
adverse cardiovascular events as studied in REDUCE-IT.
Indication and Usage Based on Current FDA-Approved Label (not
including REDUCE-IT results)
- Vascepa (icosapent ethyl) is indicated as an adjunct to diet to
reduce triglyceride (TG) levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia.
- The effect of VASCEPA on the risk for pancreatitis and
cardiovascular mortality and morbidity in patients with severe
hypertriglyceridemia has not been determined.
Important Safety Information for Vascepa Based on Current
FDA-Approved Label (not including REDUCE-IT results) (Includes Data
from Two 12-Week Studies (n=622) (MARINE and ANCHOR) of Patients
with Triglycerides Values of 200 to 2000 mg/dL)
- Vascepa is contraindicated in patients with known
hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of
its components.
- In patients with hepatic impairment, monitor ALT and AST levels
periodically during therapy.
- Use with caution in patients with known hypersensitivity to
fish and/or shellfish.
- The most common reported adverse reaction (incidence >2% and
greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for
placebo). There was no reported adverse reaction >3% and greater
than placebo.
- Adverse events and product complaints may be reported by
calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088. Patients
receiving treatment with VASCEPA and other drugs affecting
coagulation (e.g., anti-platelet agents) should be monitored
periodically.
- Patients should be advised to swallow Vascepa capsules whole;
not to break open, crush, dissolve, or chew Vascepa.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT
WWW.VASCEPA.COM.
Important Safety Information for Vascepa based on REDUCE-IT, as
previously reported in The New England Journal of Medicine
publication of the primary results of the REDUCE-IT study:
- Excluding the major adverse cardiovascular events (MACE)
results described above, overall adverse event rates in REDUCE-IT
were similar across the statin plus VASCEPA and the statin plus
placebo treatment groups.
- There were no significant differences between treatments in the
overall rate of treatment emergent adverse events or serious
adverse events leading to withdrawal of study drug.
- There was no serious adverse event (SAE) occurring at a
frequency of >2% which occurred at a numerically higher rate in
the statin plus Vascepa treatment group than in the statin plus
placebo treatment group.
- Adverse events (AEs) occurring in 5% or greater of patients and
more frequently with Vascepa than placebo were: °
peripheral edema (6.5% Vascepa patients versus 5.0% placebo
patients), although there was no increase in the rate of heart
failure in VASCEPA patients ° constipation (5.4%
Vascepa patients versus 3.6% placebo patients), although mineral
oil, as used as placebo, is known to lower constipation, and
° atrial fibrillation (5.3% Vascepa patients versus 3.9%
placebo patients), although there were reductions in rates of
cardiac arrest, sudden death and myocardial infarctions observed in
Vascepa patients
- There were numerically more SAEs related to bleeding in the
statin plus Vascepa treatment group although overall rates were low
with no fatal bleeding observed in either group and no significant
difference in adjudicated hemorrhagic stroke or serious central
nervous system or gastrointestinal bleeding events between
treatments.
- In summary, Vascepa was well tolerated with a safety profile
generally consistent with clinical experience associated with
omega-3 fatty acids and current FDA-approved labeling of such
products.
About AmarinAmarin Corporation plc. is a
rapidly growing, innovative pharmaceutical company focused on
developing therapeutics to improve cardiovascular health. Amarin’s
product development program leverages its extensive experience in
polyunsaturated fatty acids and lipid
science. Vascepa (icosapent ethyl) is Amarin's first
FDA-approved drug and is available by prescription in the United
States, Lebanon and the United Arab Emirates. Amarin’s commercial
partners are pursuing additional regulatory approvals
for Vascepa in Canada, China and the Middle East. For
more information about Amarin, visit www.amarincorp.com.
Forward-Looking StatementsThis press release
contains forward-looking statements, including statements regarding
the use of Vascepa to potentially help millions of patients and
expectations regarding regulatory review. 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, clinical trials and related
regulatory reviews and approvals; the risk that data
interpretations or other information from third parties, the
regulatory review process and the scope of any granted new
indication from regulatory reviews and approvals; the risk that
special protocol assessment (SPA) agreements with the FDA are not a
guarantee that FDA will approve a product candidate; the risk
associated with the FDA's rescinding the REDUCE-IT SPA agreement;
and the risk that the FDA may not complete its review of the
REDUCE-IT sNDA within the timing expected. 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.
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
investor.relations@amarincorp.com
Lee M. SternSolebury TroutIn U.S.: +1 (646) 378-2992
lstern@soleburytrout.com
Media Inquiries:Gwen FisherCorporate
Communications Amarin Corporation plcIn U.S.: +1 (908) 325-0735
pr@amarincorp.com
References
1 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk
Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J
Med 2019;380:11-22.
2 American Heart Association. Heart Disease and Stroke
Statistics – 2019 Update: A Report from the American Heart
Association. Published January 31, 2019.
3
https://icer-review.org/wp-content/uploads/2019/02/ICER_CVD_Final_Evidence_Report_10.17.19.pdf.
4 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk
Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J
Med 2019;380:11-22.
5 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk
Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J
Med 2019;380:11-22.
6 American Heart Association. Heart Disease and Stroke
Statistics – 2019 Update: A Report from the American Heart
Association. Published January 31, 2019.
7 American Heart Association / American Stroke Association..
2017. Cardiovascular disease: A costly burden for America
projections through 2035.
8 American Heart Association: Heart Disease and Stroke
Statistics -- 2019 At-a-Glance.
9 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.
10 Budoff M. Triglycerides and triglyceride-rich lipoproteins in
the causal pathway of cardiovascular disease. Am J Cardiol.
2016;118:138-145.
11 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.
12 Nordestgaard BG. Triglyceride-rich lipoproteins and
atherosclerotic cardiovascular disease - New insights from
epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.
13 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular
disease. Lancet. 2014;384:626–635.
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