FDA advisers recommmend CV trial for Vascepa (Amarin)
Amarin Corporation had submitted a Supplemental New Drug Application (sNDA) with the FDA seeking approval for the marketing and sale of Vascepa (icosapent ethyl) capsules for additional use as an adjunct to diet in the treatment of adult patients with high triglycerides and with Mixed Dyslipidemia (ANCHOR indication).
A panel of advisers to the FDA on 16 October condidered that Amarin should be required to complete its ongoing cardiovascular outcomes trial (REDUCE-IT) before the FDA permits the company to expand the labeling for Vascepa.
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