FDA OKs Expanded Indication for Vascepa in Cardiovascular Risk Reduction


Officials with the FDA have approved a new indication and label expansion for icosapent ethyl (Vascepa, Amarin).

FDA approval

Officials with the FDA have approved a new indication and label expansion for icosapent ethyl (Vascepa, Amarin), making it the first FDA-approved medication for reducing cardiovascular risk beyond cholesterol lowering therapy in high-risk patients approved for treatment, according to a press release.

Icosapent ethyl is indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride levels (≥150 mg/dL) and established cardiovascular disease (CVD) or diabetes, and 2 or more additional risk factors for CVD, according to Amarin.

The approval of this new indication is based on the global REDUCE-IT CV outcomes study. In the study, approximately 28% of patients in the control arm treated with statins and other contemporary therapy but not treated with icosapent ethyl experienced a major adverse CV event (MACE), defined as the first occurrence of either heart attack, stroke, coronary revascularization, unstable angina requiring hospitalization, or CV death.

In a group of patients who, despite controlling their cholesterol on statin therapy, continued to have a high need for additional preventative CV care, icosapent ethyl is the first drug approved to help reduce this persistent CV risk. A 5-year exploratory analysis of icosapent ethyl, which examined total CV events over this time period, showed that patients taking icosapent ethyl experienced 1 fewer MACE per 6 patients studied. This represented a 30% risk reduction in total MACE compared with placebo, according to the results.

In terms of safety, rates of adverse events (AEs) and serious AEs in the study were similar between patients treated with icosapent ethyl and patients treated with a placebo.

According to Amarin, “today’s announced new indication for Vascepa is incremental to its indication for which it was initially FDA approved, as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.”

“The FDA approval of icosapent ethyl as an addition to statin therapy to reduce the risk of cardiovascular events is a major milestone in cardiovascular prevention,” Deepak L. Bhatt, MD, MPH, executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, professor of medicine at Harvard Medical School, and lead investigator of the REDUCE-IT study, said in a statement. “Nothing this significant has happened in the world of cardiovascular prevention since the introduction of statin nearly 3 decades ago. Many patients stand to benefit from this historic advance in care.”


Amarin Receives FDA Approval of Vascepa (Icosapent Ethyl) to Reduce Cardiovascular Risk [news release]. Amarin’s website. https://investor.amarincorp.com/news-releases/news-release-details/amarin-receives-fda-approval-vascepar-icosapent-ethyl-reduce. Accessed December 13, 2019.

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