Vascepa is a prescription medication used to reduce the risk of cardiovascular events in certain adult patient groups. The drug contains the active ingredient icosapent ethyl, which is a highly purified form of the omega-3 fatty acid eicosapentaenoic acid (EPA) [3]. According to the sources provided, Vascepa has been on the market since 2012 [1].
The FDA approved Vascepa in July 2012 for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL) [3]. In December 2019, the FDA approved an expanded indication for Vascepa to reduce the risk of cardiovascular events in certain adult patient groups [3].
The expanded indication was based on the results of the REDUCE-IT trial, which found that Vascepa reduced the risk of major cardiovascular events by 25% in patients with elevated triglyceride levels who were already receiving statin therapy [2]. This was the first drug approved by the FDA to reduce cardiovascular risk in this patient population [3].
In summary, Vascepa has been on the market since 2012 and was initially approved for use in adult patients with severe hypertriglyceridemia. In December 2019, the FDA approved an expanded indication for Vascepa to reduce the risk of cardiovascular events in certain adult patient groups. This approval was based on the results of the REDUCE-IT trial [1][2][3].
Sources:
[1] https://www.drugpatentwatch.com/p/tradename/VASCEPA
[2] https://openheart.bmj.com/content/8/1/e001616
[3] https://www.fda.gov/news-events/press-announcements/fda-approves-use-drug-reduce-risk-cardiovascular-events-certain-adult-patient-groups