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Endocrinologic and Metabolic Drugs Advisory Committee
November 14, 2019
The committee will discuss supplemental new drug application202057/S-035,for VASCEPA(icosapent ethyl)capsules for oral administration, sponsored by Amarin Pharma Inc.,for the following proposed indication: to reduce the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerideslevels (135 mg/dL or greater) and other risk factors for cardiovascular disease,based on the results of a clinicalstudy entitled “AStudy of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT)” (available at:https://clinicaltrials.gov/ct2/show/NCT01492361 ).