The FDA Dec. 13 approved Amarin Pharmaceuticals' drug, Vascepa, a fish oil-derived pill designed to treat cardiovascular events.
The drug is approved as a secondary therapy to reduce the risk of cardiovascular events in patients with a history of cardiovascular disease or who have diabetes and two or more additional risk factors for cardiovascular disease.
The FDA's limitations on the drug's usage are stricter than what Amarin intended, STAT reported.
Vascepa is the first FDA-approved drug to reduce cardiovascular risk in patients with elevated triglyceride levels as an add-on to statin therapy. High levels of triglycerides can cause hardening of arteries and thickening of the artery wall, increasing the risk of heart attack or stroke.
In a clinical trial, patients taking Vascepa were significantly less likely to experience a cardiovascular event such as heart attack or stroke. But the FDA wrote that "the mechanisms of action that contribute to reduced cardiovascular events among patients taking Vascepa are not completely understood."
Vascepa is made from eicosapentaenoic acid, which is derived from fish oil. It is different than over-the-counter fish oil supplements because it contains just one of the fatty acids that have potential health benefits, which may give it benefits unpurified fish oil doesn't have, according to STAT.
The FDA warned that patients with allergies to fish or shellfish should be advised about the risk for allergic reactions.
Read the full article here.
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