The U.S. Food and Drug Administration on Friday gave expanded approval to a prescription form of fish oil called Vascepa, to help prevent heart trouble in people at high risk who are already taking statins. Vascepa (icosapent ethyl) was already FDA-approved for a small percentage of patients with exceptionally high blood levels of triglycerides, a type of blood fat. The new approval greatly expands the potential pool of patients, because it now includes people with simply high levels of triglycerides — at or above 150 milligrams per deciliter — and multiple risk factors for heart disease and diabetes. “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,” Dr. John Sharretts said in an FDA news release. He’s acting deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. Vascepa is a drug derived from fish that contains pure EPA, a key nutrient in fish oil. A month’s supply of Vascepa costs roughly $300. Friday’s approval follows on the positive results of a study on Vascepa presented in November at the annual meeting of the American Heart Association (AHA). Early findings from the clinical trial found that the drug slowed the development of artery-clogging… read on >

















