Oct 16 (Reuters) - Amarin Corporation Plc's triglyceride-lowering drug Vascepa should not be approved foruse in a broader patient population, an advisory panel to theU.S. Food and Drug Administration said on Wednesday.
The panel voted 9-2 against approval of Vascepa for use incombination with a cholesterol-lowering statin such as PfizerInc's Lipitor in patients at high risk of coronary heartdisease.
The drug is currently approved as a standalone treatment tolower triglycerides in adults. While the drug appears to reducetriglycerides in the wider patient group, the panel was notconvinced that lowering triglycerides would lead to a reductionin the risk of coronary heart disease or death.
The FDA is not bound to follow the recommendations of itsadvisory panels but typically does so. (Reporting by Toni Clarke in Washington; Editing by BernardOrr)