VASCEPA® development employs state-of-the-art, FDA-regulated manufacturing
and packaging processes designed to protect the active ingredient from degradation from early stages of the
manufacturing process through administration of the drug to patients. Study of VASCEPA®
has included a broad range of laboratory and clinical assessments, including three successfully completed
Phase 3 studies, the MARINE, ANCHOR and REDUCE-IT studies, the results of which were published in 2011, 2012
and 2019, respectively. The aggregate cost of developing VASCEPA® has exceeded
$500 million.
VASCEPA® (icosapent ethyl) capsules, was originally approved in 2012 to
reduce severely elevated levels of triglycerides (500 milligrams per deciliter or higher), along with diet
and exercise, in adult patients. This drug’s approval was expanded in 2019 as an adjunct to maximally tolerated
statin therapy to reduce the risk of cardiovascular events in certain adults with elevated triglyceride levels
of 150 milligrams per deciliter or higher and other cardiovascular risk factors. This is the first and only
FDA approved drug to reduce cardiovascular risk in patients with elevated triglyceride levels as an add-on to
maximally tolerated statin therapy. Statins are drugs used to treat elevated cholesterol levels and reduce
the risk of cardiovascular events. VASCEPA® is a prescription medicine used
along with certain medicines (statins) to reduce the risk of heart attack, stroke and certain types of heart
issues requiring hospitalization in adults with heart (cardiovascular) disease, or diabetes and two (2) or
more additional risk factors for heart disease.
VASCEPA® is a drug, not a food product
VASCEPA® is a pure, proven and prescription drug consisting of icosapent
ethyl, a single-molecule medicine derived from nature. The science underlying the development and mechanisms
of action of VASCEPA® is extensive and complex. Medical treatment guidelines
emphasize that the positive clinical results demonstrated with VASCEPA® should not be generalized to any other
product.
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Many approved prescription drugs used today had their origins in nature, which provides an important
resource for drug development. In fact, up to 50% FDA-approved drugs during the last 30 years were from a
natural source, directly or indirectly. For example, in the area of cancer, from the mid-20th century
approximately half of the small molecules approved for treatment were either natural products or directly
derived from nature1
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VASCEPA® is derived from small, wild, ocean-dwelling fish (e.g.,
sardines and anchovies), the supply of which is tightly regulated by governing bodies to ensure
sustainability. VASCEPA® is manufactured to FDA drug standards
through a purification process designed to eliminate impurities and protect its fragile active
ingredient from damage starting from the distillation of active ingredient and through dose
administration.
Common fish oil is available on retail shelves and online without a prescription as a dietary supplement.
Common fish oil is not a substitute for VASCEPA®.
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Common fish oil is not intended nor proven safe and effective to treat patients with medical conditions.
It is not a drug. Manufacturers of fish oil have sought FDA approval for claims associated with improving
disease conditions and such applications have been denied by the FDA due to a lack of adequate and consistent
evidence. In the statin era, published summaries of fish oil studies have shown that such products consistently
fail to demonstrate cardiovascular benefit.
-
Under FDA regulations, fish oil and other dietary supplements are classified as food – not as
prescription drugs. Such products have failed in clinical trials to demonstrate the safety and efficacy
required of an FDA-approved pharmaceutical product.
Further, dietary supplements such as common fish oils are not governed by the same stringent FDA manufacturing
regulations as drugs and are not required to be FDA-approved before being sold to
consumers.2,3
The FDA designated VASCEPA® as a new chemical entity (NCE). Common fish oil
does not have this distinction. The FDA has approved VASCEPA® for the reduction
of cardiovascular risk as an add-on to maximally tolerated statin therapy in patients with elevated triglyceride
levels and other risk factors. No fish oil product, or any other product, has such an approval.
-
The NCE designation signifies that the single active molecule that comprises
VASCEPA® was not previously approved by the FDA to treat or prevent a
medical condition. VASCEPA®’s active ingredient is derived from nature with
unique effect.
-
It is VASCEPA®’s distinct purity, manufacturing processes, stability,
clinical effect, safety profile and proven clinical results together with FDA approval and oversight that
makes the drug different from common fish oil.
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In FDA-reviewed clinical studies, pure VASCEPA® showed a different clinical
profile than prior generation omega-3 drug product mixtures. For example, VASCEPA®
lowered triglycerides without raising bad cholesterol, LDL-C, in patients with very high triglycerides.
VASCEPA® also reduced cardiovascular events in studied patients. Attempts by
other omega-3 products to show similar results beyond modern statin therapy have consistently failed.
Indications and Limitation of Use
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
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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.
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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%).
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Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than
placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
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Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
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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®, which is available for
download here.
1 J Nat Prod. 2016 Mar 25;79(3):629-61. doi: 10.1021/acs.jnatprod.5b01055.
Epub 2016 Feb 7. https://www.ncbi.nlm.nih.gov/pubmed/26852623
2 R. Preston Mason and Samuel C.R. Sherratt, Omega-3 fatty acid fish oil dietary
supplements contain saturated fats and oxidized lipids that may interfere with their intended biological benefits,
Biochemical and Biophysical Research Communications (2016)
3 Supplements and Safety, S34 E3, Frontline, PBS (Jan. 2016) at 39:30, available at
http://www.pbs.org/video/frontline-supplements-and-safety/