(Reuters) - Amarin Corp Plc said the 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Amarin said on October 29 that the FDA rescinded the agreement which guaranteed that the design of a late-stage trial of Amarin’s triglyceride-lowering drug Vascepa was adequate to support a marketing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.
Vascepa is already approved to reduce triglycerides in patients who are not taking statins. Amarin is awaiting FDA decision on the use of the drug for the broader population. The decision is expected to come in by December 20.
The FDA had said a substantial scientific issue essential to evaluating the effectiveness of Vascepa in the study was identified after the testing began.
The FDA notified Amarin on Thursday that the company’s request for a meeting at a high level within the agency regarding the appeal was not granted.
The company said it planned to pursue the appeal.
Amarin shares closed at $1.99 on the Nasdaq on Thursday.
Reporting by Esha Dey in Bangalore; Editing by Don Sebastian