FDA approved the use of icosapent ethyl (Vascepa, Amarin Pharma) as an adjunctive therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels of 150 mg. per deciliter or higher - the first FDA-approved treatment of its type.
Vascepa’s active ingredient is the omega-3 fatty acid, eicosapentaenoic acid, derived from fish oil.
“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,” says John Sharretts, MD, acting deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, in a statement.
Patients who take Vascepa must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease, FDA says.
Vascepa was initially approved in 2012 for adults with severe triglyceride levels, and FDA granted priority review to Amarin’s supplemental application for the drug.
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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.
However, 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, FDA says.
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,” the agency says.