Amarin Corp Plc said the U.S. Food and Drug Administration did not accept its appeal for the review of a regulatory decision to revoke an agreement related to the trial of its lead drug that lowers a type of blood fat. Amarin said on Oct. 29 that the FDA rescinded the agreement which guaranteed that the design of a late-stage trial of Amarin’s triglyceride-lowering drug Vascepa was adequate to support a marketing application. The trial, Anchor, was testing Vascepa in patients who also take a cholesterol-lowering statin such as Pfizer Inc’s Lipitor and are at a high risk of coronary heart disease.
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