(Adds analyst comment in paragraph 7)
By Toni Clarke
Oct 16 (Reuters) - Amarin Corporation Plc's triglyceride-lowering drug Vascepa should not be approved foruse in a broader patient population until results from anadditional study have been analyzed, an advisory panel to theU.S. Food and Drug Administration said on Wednesday.
The panel voted 9-2 against approval of the drug forpatients who also take a cholesterol-lowering statin such asPfizer Inc's Lipitor and are at high risk of coronaryheart disease.
While the drug reduced triglycerides, or blood fats, in aclinical trial, the panel was not convinced that loweringtriglycerides would automatically lead to a reduced risk ofcoronary heart disease or death.
The FDA is not bound to follow the recommendations of itsadvisory panels but typically does so.
Vascepa is already approved to reduce triglycerides inpatients who are not taking statins. Amarin had hoped to marketthe drug to a much broader patient population. But Dr. DavidCooke, clinical director of pediatric endocrinology at JohnsHopkins University School of Medicine and a panelist, said it"has not yet been proven" that Vascepa, or any medication thatlowers blood fats, except statins, decreases cardiovascularrisk.
The FDA suggested that approval should be withheld pendingthe results of an 8,000-patient trial being conducted by Amarinthat is expected to shed light on whether Vascepa actually cutscardiovascular risk. Results of the trial are expected in late2016.
Raghuram Selvaraju, an analyst at Aegis Capital Corp, saidthe company will "in all likelihood need to raise additionalcapital" in order to fund operations through to the release ofthose results. While those results "could still vindicateAmarin," he said, "we believe that moving to the sidelines isprobably the most appropriate strategy at this juncture."
Selvaraju cut his recommendation on the stock to "hold" from"buy."
Amarin's shares were halted on Wednesday pending the FDApanel's discussion. They fell to a year-low of $4.50 on Mondayfollowing publication of the FDA's initial review of thecompany's application, which was more cautious than investorshad expected.
Vascepa is a purified ethyl ester of eicosapentaenoic acid(EPA) derived from fish oil. EPA, along with a-linolenic acidand docosahexaenoic acid (DHA) are collectively referred to asomega-3 fatty acids.
EPA and DHA are also the major constituents of fish oilsderived from cold water fish. The only other approved fish-oiltreatment for severe hypertriglyceridemia is Lovaza, which ismade by GlaxoSmithKline Plc. Lovaza has not been shownto cut the rate of heart attack or stroke. (Reporting by Toni Clarke in Washington; Editing by BernardOrr)