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.

• 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
• 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®.

• 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.
• 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
• 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®, 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/