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ANCHOR Indication For Amarin’s Vascepa Will Face FDA Panel Scrutiny

This article was originally published in The Pink Sheet Daily

Executive Summary

Key question at the Oct. 16 advisory committee review could be whether FDA should wait for results from an ongoing cardiovascular outcomes trial before significantly broadening the prescription fish oil product’s approval to include adults with high triglycerides and mixed dyslipidemia.

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Omega-3 Questions Could Pull Plug On Sales Growth

Pharma firms’ introduction and wide promotion of Rx drugs containing EPA or DHA acids and aimed at improving cardiovascular health were expected to boost omega-3 supplement sales, but negative research results reported over the past year could diminish consumers’ regard for the nutrients’ benefits.

Panel To Weigh Amarin’s Expanded Vascepa Use Given Clinical Outcome Concerns

FDA advisors will discuss Oct. 16 whether Vascepa’s effect on reducing triglycerides is enough to overcome concerns about this surrogate endpoint not panning out in other drug’s clinical outcomes trials.

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