Nov 22 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Amarin said on Oct. 29 that the FDA rescinded the agreement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.
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 Dec. 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.