The approval reverses decades of mixed results for fish-oil-based drugs and could result in Vascepa being prescribed to millions of patients. Amarin, the drug’s maker, set a list price of $303.65 per month.
The Associated Press: US Approves Fish Oil-Based Drug For Cutting Heart Risks U.S. regulators on Friday approved expanded use of a fish oil-based drug for preventing serious heart complications in high-risk patients already taking cholesterol-lowering pills. Vascepa was approved years ago for people with sky-high triglycerides, a type of fat in blood. The Food and Drug Administration allowed its use in a far bigger group of adults with high, but less extreme, triglyceride levels who have multiple risk factors such as heart disease and diabetes. (Johnson, 12/13) The Wall Street Journal: FDA Approves Fish-Oil-Derived Drug For Use Preventing Heart Attacks, Strokes The drug, Vascepa from Amarin Corp. PLC, now becomes a new tool for reducing the risk of heart attacks, strokes and deaths in millions of heart-disease or diabetes patients with elevated triglycerides while opening up a multibillion-dollar commercial opportunity for its maker. The expanded label could mean Vascepa sales surpass $3 billion, analysts say. Last year’s sales approached $230 million. Vascepa was approved in the U.S. in 2012 to treat adults with severe hypertriglyceridemia, or very high levels of triglycerides, which are fats that circulate in the blood. Since then, Amarin has been exploring whether the drug’s effect goes further by reducing the risk of heart disease. (Hopkins, 12/13) Reuters: FDA Says Amarin Can Market Fish-Oil Derived Therapy For Reducing Heart Attack Risk 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. 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. (Joseph, 12/13) Stat: FDA Approves Amarin Fish-Oil-Derived Drug To Prevent Heart Attacks And Strokes The FDA decided to limit the use of Vascepa more than Amarin had initially requested. Vascepa will be approved for patients who already have established cardiovascular disease — meaning they have had a problem like a heart attack or chest pain that appeared quickly — or for those who have diabetes and two risk factors for heart attacks. Vascepa is approved for use in patients who have levels of triglycerides, or particles of fat in the blood, that are above 150 milligrams per deciliter, slightly higher than the 135 mg/dL Amarin requested. (Herper, 12/13)
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