CATO Exclusive | Impurity Reference Standards for Eicosapentaenoic Acid (EPA)

Eicosapentaenoic acid (EPA) is an omega-3 polyunsaturated fatty acid indicated for lowering triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL). Studies have shown that 4 g/day of eicosapentaenoic acid ethyl ester administered for 12 weeks can reduce triglyceride levels by approximately 16%-26%.

On July 26, 2012, the U.S. Food and Drug Administration (FDA) approved Amarin's icosapent ethyl soft capsules (trade name: Vascepa) for the treatment of hypertriglyceridemia, making it the second prescription omega-3 polyunsaturated fatty acid on the market.

In December 2019, icosapent ethyl became the only FDA-approved adjunct therapy to maximally tolerated statin therapy and the first approved drug shown to effectively reduce the risk of residual cardiovascular events. The therapeutic efficacy of EPA ethyl ester in cardiovascular disease has been widely recognized.

In addition, eicosapentaenoic acid

has many other important functions and benefits in the human body:

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