(Reuters) – A panel of experts to the U.S. FDA recommended allowing Amarin Corp Plc’s fish-oil derived drug to be used as an add-on therapy for reducing the chance of heart attacks and strokes in high-risk patients with cardiovascular disease.
The panel on Thursday voted 16-0 in favor of expanding approval, potentially opening up a multi-billion dollar opportunity for Amarin which has only one drug, Vascepa, in the market.
Vascepa, a highly purified form of omega-3 fatty acid, won U.S. approval in 2012 to lower high levels of triglycerides.
“There is no doubt this is a medication that could benefit a substantial portion of the U.S. and meets an unmet need,” said panel member Dr. Jack Yanovski of the National Institutes of Health.
The FDA, which has set a target date of Dec. 28 to decide on the label expansion, is not mandated to follow the recommendation of the panel, but generally does.
A late-stage trial last year found Vascepa, when administered to patients on…
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