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

U.S. health regulators on Friday approved expanding the heart benefit claims Ama...

- 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.

Vascepa, a highly purified form of omega-3 fatty acid, won U.S. approval in 2012 to lower high triglycerides - a type of blood fat that can increase the risk of heart disease. Vascepa has been heralded as a potential game changer in the cardiovascular disease market by Wall Street analysts. 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 $3,600 is much lower than the non-profit group’s recommended value-based price range of $6,300 to $9,200.

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