Vascepa (icosapent ethyl) has been approved by the US Food and Drug Administration (FDA) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels (a type of fat in the blood) of 150mg per deciliter or higher.

The FDA has said that patients who use this drug must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease. Patients are advised to continue physical activity and maintain a healthy diet.

Vascepa, which is taken orally, is the first FDA approved drug to reduce cardiovascular risk among 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.

"The FDA recognises there is a need for additional medical treatments for cardiovascular disease," said John Sharretts, MD, Acting Deputy Director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. "Today’s approval will give patients with elevated triglycerides and other important risk factors, including heart disease, stroke and diabetes, an adjunctive treatment option that can help decrease their risk of cardiovascular events."

The FDA said that Vascepa’s efficacy and safety were established in a study with 8,179 patients who were either 45 years and older with a documented history of coronary artery, cerebrovascular, carotid artery and peripheral artery disease, or 50 years and older with diabetes and additional risk factors for cardiovascular disease.

Patients who received Vascepa were significantly less likely to experience a cardiovascular event, such as a stroke or heart attack, the administration continued and its active ingredient is the omega-3 fatty acid, eicosapentaenoic acid, derived from fish oil. 

The FDA said that Vascepa was initially approved in 2012 for adults with severe triglyceride levels. This supplement application received Priority Review, which it grants to applications for drugs that, if approved, would improve the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.

The approval of Vascepa was granted to Amarin Pharma Inc. 

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