FDA Balks At Trial Design For Amarin's Fish Oil Drug

Law360, New York (January 21, 2014, 7:21 PM EST) -- Ireland-based Amarin Corp. PLC on Tuesday disclosed that the U.S. Food and Drug Administration has refused to reconsider its rejection of a clinical trial agreement aimed at dramatically widening use of fish oil product Vascepa, an expected development that the company plans to appeal.

Vascepa is approved for patients with extremely high triglyceride levels, and Amarin is hoping to broaden that indication, but its path was blocked when the FDA rescinded a so-called special protocol assessment that gives drugmakers confidence their trial designs will support approval...
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