FDA says Amarin can market fish-oil derived therapy for reducing heart attack risk

REUTERS: U.S. health regulators on Friday approved expanding the heart benefit claims Amarin Corp can make in promoting its drug Vascepa to include reducing the risk of heart attacks and strokes in high-risk patients, opening a multibillion-dollar market opportunity.

The expanded label allows the company to tap into a market of up to 15 million Americans at risk of developing cardiovascular complications despite being on statin treatment to lower cholesterol. Vascepa has been heralded as a potential game changer in the cardiovascular disease market by Wall Street analysts.In clinical trials, Vascepa cut the combined rate of heart attacks, strokes, heart-related death, need for artery-clearing procedures and hospitalizations for unstable angina by 25per cent compared to placebo. That comes on top of the heart attack risk reduction of about 25per cent patients already get from statins.

Vascepa has been highlighted as a cost-effective add-on to statins by the Institute for Clinical and Economic Review. The therapy's annual cost based on list price of around US$3,600 is much lower than the non-profit group's recommended value-based price range of US$6,300 to US$9,200.

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