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

 
• By Sue Sutter

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.

The FDA Endocrinologic and Metabolic Drugs Advisory Committee’s review of Amarin Corp. PLC’s Vascepa (icosapent ethyl) may come down to the question of whether the agency should await results of a large, ongoing cardiovascular outcomes trial before greatly expanding the prescription fish oil product’s approved indication.

On June 19, Amarin announced that FDA has informed the company it will convene an advisory committee Oct

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