On Dec. 13, Vascepa (icosapent ethyl) became the first U.S. Food and Drug Administration (FDA)-approved medication for reducing cardiovascular risk beyond cholesterol lowering therapy in high-risk patients approved for treatment.

The drug was approved specifically "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 and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease." Vascepa was initially approved in 2012 for adults with severe triglyceride levels. Patients with allergies to fish or shellfish should be advised about the potential for allergic reactions and should discontinue treatment and seek medical attention if any allergic reactions occur.

Read the full FDA announcement here.

Keywords: ACC Advocacy, United States Food and Drug Administration, Myocardial Infarction, Stroke, Diabetes Mellitus

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