Amarin (NASDAQ:AMRN) is up 20% premarket on robust volume in reaction to the release of meeting materials for Thursday’s meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meeting to review and discuss the company’s application for a CV benefit claim for Vascepa (icosapent ethyl) based on results from the large-scale REDUCE-IT study.
Citing the summary (FDA briefing doc, page 103), the FDA review team believes that the benefit-risk profile for CVD risk reduction is favorable.
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