A panel of experts to the US Food and Drug Administration has unanimously recommended allowing a fish-oil derived drug as an add-on therapy for reducing the chance of heart attacks and strokes in high-risk patients with cardiovascular disease (CVD).
Reuters Health reports that the panel voted 16-0 in favour of expanding approval, potentially opening up a multi-billion-dollar opportunity for Amarin, which has only one drug, Vascepa, in the market.
The report says Vascepa, a highly purified form of omega-3 fatty acid, won US 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 US 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 28 December 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 cholesterol-lowering drug statin, cut the combined rate of heart attacks, strokes and other cardiovascular events by 25% compared to a placebo.
The report says the panel was largely in favour of an approval in patients with history of cardiovascular disease, but some members were unconvinced of the drug’s effectiveness in reducing cardiac events in patients who have not had strokes or heart attacks, or any other such events.
Some patients in the trial reported slightly higher risk of bleeding and a small increase in irregular heart rhythm, safety concerns that panel members suggested highlighting on the drug’s label.Reuters Health report