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# Amarin Files sNDA for Vascepa CV Outcomes
- URL: https://www.fdaweb.com/amarin-files-snda-for-vascepa-cv-outcomes/
- Published: 2019-03-29T12:00:00.000Z
- Updated: 2026-09-15T01:16:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143741

Amarin has submitted a supplemental NDA seeking an expanded indication for Vascepa (icosapent ethyl) capsules based on data from the REDUCE-IT cardiovascular (CV) outcomes study. “The REDUCE-IT results support that approximately one fewer major cardiovascular adverse event would occur on average for every six patients treated with Vascepa for five years on top of statin therapy compared to placebo,” the company says. Currently, the drug is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.

According to the company, Vascepa use in REDUCE-IT provided a “25% relative risk reduction compared to placebo in the first occurrence of a major adverse CV event (MACE) in the intent-to-treat population consisting of a composite of cardiovascular death, nonfatal myocardial infarction (MI or heart attack), nonfatal stroke, coronary revascularization (procedures such as stents and by-pass) and unstable angina requiring hospitalization. For total (first and subsequent) cardiovascular events, Vascepa provided a statistically significant 30% risk reduction compared to placebo in the statin-treated patient population studied in REDUCE-IT.”

The company is expecting a 10-month FDA review with an action target date of 01/2020.