FDA Approves Icosapent Ethyl to Reduce Risk of Cardiovascular Event for Adults with Elevated Triglyceride Levels

Icosapent ethyl is the first FDA-approved prescription form of fish oil to reduce cardiovascular risk among patients with triglyceride levels as an add-on to maximally tolerated statin therapy.

The FDA has approved icosapent ethyl (Vascepa, Amarin), the prescription form of fish oil, as an adjunctive therapy taken orally to reduce the risk of cardiovascular events among adults with elevated triglyceride levels of 150 mg per deciliter or higher.

Icosapent ethyl is the first FDA-approved drug to reduce cardiovascular risk among patients with triglyceride levels as an add-on to maximally tolerated statin therapy. Statins are prescribed to treat elevated cholesterol levels and reduce the risk of cardiovascular events.

The approval is based off of a study that included 8179 patients who were either age 45 years or older with a documented history of coronary artery, cerebrovascular carotid artery, and peripheral artery disease, or age 50 years and older with diabetes and additional risk factors for cardiovascular disease. Patients who received icosapent ethyl were significantly less likely to experience a cardiovascular event, such as a stroke or heart attack.

Icosapent ethyl’s active ingredient is an omega-3 fatty acid, eicosapentaenoic acid, which is derived from fish oil. It was initially approved in 2012 for adults with severe triglyceride levels. This supplement application received Priority Review.

The report noted that patients must also have either established cardiovascular disease or diabetes and 2 or more additional risk factors for cardiovascular disease. Furthermore, patients should continue physical activity and maintain a healthy diet in addition to the therapy.

Reference

FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups [press release]. FDA website. Published December 13, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-use-drug-reduce-risk-cardiovascular-events-certain-adult-patient-groups. Accessed December 16, 2019.