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# Amarin Gains Expanded Use for Vascepa
- URL: https://www.fdaweb.com/amarin-gains-expanded-use-for-vascepa/
- Published: 2019-12-13T12:00:00.000Z
- Updated: 2026-09-14T15:56:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145726

FDA has approved the expanded use of Amarin’s Vascepa’s (icosapent ethyl) to reduce the risk of cardiovascular events as an adjunct to statin therapy in adults with elevated triglycerides and other cardiovascular disease risk factors. Last month, the agency’s Endocrinologic and Metabolic Diseases Advisory Committee voted 16 to 0 to recommend the drug’s expanded approval. Vascepa was initially approved in 2012 for adults with severe triglyceride levels.

The positive panel vote came on the basis of data from the [REDUCE-IT trial](https://clinicaltrials.gov/ct2/show/NCT01492361?ref=fdaweb.com) and despite FDA highlighting two new safety signals that were not seen before. A [briefing document ](https://www.fda.gov/media/132477/download?ref=fdaweb.com)said that more patients treated with Vascepa in the REDUCE-IT trial experienced atrial fibrillation or atrial flutter requiring hospitalization. And more patients treated with the drug also experienced a bleeding event such as gastrointestinal bleeding or contusions.

FDA reviewers noted that Vascepa treatment led to a 25% reduction in heart risks compared to placebo. However, they said, questions have remained about whether use of a mineral oil placebo inflated the drug’s reported benefit. The reviewers indicated they were not able to conclusively prove that hypothesis and said that in any case the impact of raised LDL levels would not have been sufficient to significantly change the clinical trial results.