For Immediate Release: December 13, 2019

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The U.S. Food and Drug Administration today approved the use of Vascepa (icosapent ethyl) 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 150 milligrams per deciliter or higher. Patients 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 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 recognizes there is a need for additional medical treatments for cardiovascular disease,” said John Sharretts, M.D., 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.”

High levels of triglycerides can play a role in the hardening of arteries or thickening of the artery wall, which can increase the risk of a heart attack or stroke; however, the mechanisms of action that contribute to reduced cardiovascular events among patients taking Vascepa are not completely understood.

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. Vascepa’s active ingredient is the omega-3 fatty acid, eicosapentaenoic acid, derived from fish oil. Vascepa is taken orally.

In clinical trials, Vascepa was associated with an increased risk of atrial fibrillation or atrial flutter (irregular heart rhythms) requiring hospitalization. The incidence of atrial fibrillation was greater among patients with a history of atrial fibrillation or atrial flutter. Vascepa was also associated with an increased risk of bleeding events. The incidence of bleeding was higher among patients who were also taking other medications that increase the risk of bleeding, such as aspirin, clopidogrel or warfarin at the same time.

Patients with allergies to fish or shellfish should be advised about the potential for allergic reactions. They should discontinue treatment and seek medical attention if any allergic reactions occur.

The most common side effects reported in the clinical trials for Vascepa were musculoskeletal pain, peripheral edema (swelling of legs and hands), atrial fibrillation and arthralgia (joint pain).

Vascepa was initially approved in 2012 for adults with severe triglyceride levels. This supplement application received Priority Review. The FDA grants priority review 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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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