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FDA Advisors Recommend Expanding Triglyceride Drug Label

November 19, 2019

In a unanimous (16-0) vote, the Endocrinologic and Metabolic Drugs Advisory Committee of the US Food and Drug Administration (FDA) recommended the approval of Vascepa (icosapent ethyl) capsules to reduce the risk of cardiovascular events in high-risk patients.

The panel’s recommendation was based on the results of the landmark REDUCE-IT cardiovascular outcomes trial, which was a global cardiovascular outcomes study geared towards assessing the effects of icosapent ethyl capsules compared with placebo in 8179 adult participants meeting the following criteria:

  • Low-density lipoprotein cholesterol controlled to 41 to 100 mg/dL via statin therapy.
  • Various cardiovascular risk factors, such as persistent elevated triglycerides between 135 and 499 mg/dL.
  • Either established cardiovascular disease or diabetes and at least 1 other cardiovascular risk factor.

Results of the trial indicated that participants treated with icosapent ethyl capsules over a median 4.9 years of follow-up experienced a 25% lower risk of major cardiovascular events compared with placebo-treated participants.

“The REDUCE-IT results are quite remarkable and illustrate how icosapent ethyl could transform the treatment of cardiovascular disease in the United States and worldwide,” said REDUCE-IT investigator Deepak L. Bhatt, MD, MPH, executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital Heart and Vascular Center, and professor of medicine at Harvard Medical School, in a press release.

“From my perspective as not only a researcher but also a practicing physician, icosapent ethyl represents one of the most important developments in the prevention and treatment of cardiovascular disease since statins and, if FDA approved, will be a critical tool for physicians to use to help prevent cardiovascular events such as heart attack and stroke, including fatal ones, in high-risk patients” Dr Bhatt added.

While the FDA is not bound by the advisory committee’s decision, it often approves drugs recommended by advisors. Vascepa’s manufacturer, Amarin Corporation, anticipates that the FDA will make its final decision on or before December 28, 2019.

—Christina Vogt

Amarin announced FDA advisory committee voted unanimously (16-0) to recommend approval of Vascepa® (icosapent ethyl) capsules label expansion to reduce cardiovascular risk based on landmark REDUCE-IT® Outcomes Trial [press release]. Dublin, IE, and Bridgewater, NJ. Amarin Corporation. November 14, 2019. Accessed November 18, 2019.

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