FDA approves omega-3 fatty acid to reduce cardiovascular risk

Vascepa; Amarin Pharma

The US Food and Drug Administration (FDA) has approved the omega-3 fatty acid icosapent ethyl (Vascepa; Amarin Pharma) as an adjunctive therapy to reduce the risk of cardiovascular events in adults with elevated triglyceride levels.

This is the first FDA-approved medicine thought to reduce cardiovascular risk among patients with elevated triglyceride levels (of 150mg/dL or higher) as an add-on to maximally tolerated statin therapy.

Eligible patients must have either established cardiovascular disease (CVD) or diabetes, as well as two or more additional risk factors for CVD. While taking the medicine, patients should be advised to continue physical activity and maintain a healthy diet.

In a statement published on 13 December 2019, John Sharretts, acting deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said: “The FDA recognises there is a need for additional medical treatments for CVD.

“[The] 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,” he added.

Vascepa, which is taken orally, was initially approved in 2012 for adults with severe triglyceride levels of 500mg/dL or higher. Since 2004, the FDA has approved four fish oil-derived products for lowering extremely high levels of triglycerides.

Last updated
The Pharmaceutical Journal, FDA approves omega-3 fatty acid to reduce cardiovascular risk;Online:DOI:10.1211/PJ.2019.20207490

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