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FDA rejects expanded use of Amarin's Vascepa

This article was originally published in Scrip

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Executive Summary

Shares of Amarin tumbled about 10% on 28 April after the company disclosed the FDA declined to expand the use of Vascepa (icosapent ethyl) in the US as an adjunct to diet to reduce triglyceride (TG) levels in adults on statin therapy with mixed dyslipidemia and TG levels from 200mg/dL to 499mg/dL – the so-called ANCHOR indication.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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