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Amarin Corporation plc Reaffirms the Proven Guideline-Recommended Role of Vascepa (Icosapent Ethyl) in an Evolving Triglyceride Treatment Landscape
Amarin Corporation plc applauds the recent FDA approval of injectable apolipoprotein C-III (APOC3) therapies for the treatment of severe hypertriglyceridemia (sHTG), defined as triglycerides (TG) greater than or equal to 500 mg/dL. These injectable therapies represent meaningful progress for patients at high risk for serious, sometimes life-threatening diseases associated with sHTG, including acute pancreatitis. For many years, clinicians have managed sHTG with proven, foundational therapies like VASCEPA, which remains a critical, first-line option for millions of individuals who have taken control of their lipid management. Issues such as cost, coverage, and accessibility may influence how and when patients are able to benefit from innovative, yet high-cost therapies. VASCEPA will continue to deliver strong clinical and economic value for a broad segment of patients with severe hypertriglyceridemia. VASCEPA has been shown to deliver a 33% median reduction in TG levels in patients with sHTG as compared to placebo, with approximately 50% of patients achieving TG levels below 500 mg/dL at 12 weeks. These reductions were achieved without the increases in LDL cholesterol observed with certain other triglyceride-lowering agents in patients with sHTG. There is a stark contrast in cost between VASCEPA and recently introduced injectable APOC3 therapies, the most recent of which carries an annual wholesale acquisition cost (WAC) of $40,000 per patient. By comparison, the annual wholesale acquisition cost for VASCEPA is approximately $4,200 per patient. Reflecting this cost differential, many payers, pharmacy benefit managers (PBMs), and managed care organizations may follow a well-established pattern of managing utilization of premium priced therapies through judicious prior authorization and step-therapy requirements. VASCEPA has been prescribed more than 30 million times globally for patients with elevated triglycerides and remains the first and only FDA-approved therapy proven to reduce the risk of cardiovascular events by 25% when added to a statin in high-risk patients with elevated triglycerides and other cardiovascular risk factors. 70+ medical societies recognize the importance of icosapent ethyl based on the strength of the clinical data. The 2026 American College of Cardiology /American Heart Association /Multisociety Dyslipidemia Guideline reaffirmed the role of established triglyceride-lowering therapies, including VASCEPA, in the management of patients with elevated triglycerides. VASCEPA (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 thirty million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Saudi Arabia, Qatar, Bahrain, and Kuwait. 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. In April 2021 marketing authorization for VAZKEPA was granted in the United Kingdom (applying to England, Scotland, Wales, and Northern Ireland). VAZKEPA is currently approved and sold in Europe in Sweden, Finland, England/Wales, Spain, Netherlands, Scotland, Greece, Portugal, Italy, Denmark and Austria. 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. VASCEPA is also indicated 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. 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%). Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.