Public healthcare agency The US Food and Drug Administration (FDA) announced on Friday that it has authorised Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels of 150 milligrams per deciliter or higher.
The US approval of Vascepa was granted to Amarin Pharma Inc.
High levels of triglycerides (a type of fat in the blood) can play a role in the hardening or thickening of the artery wall, which can increase the risk of a heart attack or stroke. The patients are advised to continue physical activity and maintain a healthy diet, said the agency.
Vascepa is reportedly 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. Vascepa's active ingredient is the omega-3 fatty acid, eicosapentaenoic acid, derived from fish oil. Vascepa is taken orally.
According to the FDA, 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.
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