Amarin Corporation Plc's triglyceride-lowering drug Vascepa should not be approved for use in a broader patient population until results from an additional study have been analyzed, an advisory panel to the U.S. Food and Drug Administration said on Wednesday.
The panel voted 9-2 against approval of the drug for patients who also take a cholesterol-lowering statin such as Pfizer Inc's Lipitor and are at high risk of coronary heart disease.
While the drug reduced triglycerides, or blood fats, in a clinical trial, the panel was not convinced that lowering triglycerides would automatically lead to a reduced risk of coronary heart disease or death.
The FDA is not bound to follow the recommendations of its advisory panels but typically does so.
Vascepa is already approved to reduce triglycerides in patients who are not taking statins. Amarin had hoped to market the drug to a much broader patient population. But Dr. David Cooke, clinical director of pediatric endocrinology at Johns Hopkins University School of Medicine and a panelist, said it "has not yet been proven" that Vascepa, or any medication that lowers blood fats, except statins, decreases cardiovascular risk.
The FDA suggested that approval should be withheld pending the results of an 8,000-patient trial being conducted by Amarin that is expected to shed light on whether Vascepa actually cuts cardiovascular risk. Results of the trial are expected in late 2016.
Raghuram Selvaraju, an analyst at Aegis Capital Corp, said the company will "in all likelihood need to raise additional capital" in order to fund operations through to the release of those results. While those results "could still vindicate Amarin," he said, "we believe that moving to the sidelines is probably 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 FDA panel's discussion. They fell to a year-low of $4.50 on Monday following publication of the FDA's initial review of the company's application, which was more cautious than investors had expected.
Vascepa is a purified ethyl ester of eicosapentaenoic acid (EPA) derived from fish oil. EPA, along with a-linolenic acid and docosahexaenoic acid (DHA) are collectively referred to as omega-3 fatty acids.
EPA and DHA are also the major constituents of fish oils derived from cold water fish. The only other approved fish-oil treatment for severe hypertriglyceridemia is Lovaza, which is made by GlaxoSmithKline Plc. Lovaza has not been shown to cut the rate of heart attack or stroke.
(Reporting by Toni Clarke in Washington; Editing by Bernard Orr)
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