US health regulators have expanded the approval of using a fish oil-based drug for reducing the risk of serious heart attacks. The Food and Drug Administration or FDA has approved the broader use of Vascepa after an independent panel voted unanimously in favor of it. The decision was taken based on positive clinical trial data. Vascepa is a highly purified form of omega-3 fatty acid. It was approved by the FDA in 2012 for people with sky-high triglycerides. Triglycerides is a type of fat in the blood that can increase the risk of heart-related diseases. The FDA has now allowed its use in a group of adults with not so extreme levels of triglyceride and having multiple risk factors like heart disease and diabetes.
The approval for expanded use allows it to tap into the market of around 15 million Americans. Vascepa is expected to control about 12 percent of the US market in the next few years. Roth Capital Partners has predicted the peak annual sales of USD 3.2 billion by 2030. Drugmaker Amarin has set a list price of USD 303.65 per month. The exact amount paid by patients will vary by insurance and the company said it will provide financial support. In clinical testing, Vascepa reduced risks of potentially deadly complications including heart attack, strokes by 25 percent. A study was conducted for five years on 8200 patients and was funded by the manufacturer. The patients were already taking medicines to control diabetes or lower bad cholesterol.
Chances of heart complications were reduced by 25 percent in patients taking Vascepa. It reduced the risk of death by 20 percent compared with patients taking dummy capsules of mineral oil. Heart disease is one of the major causes of deaths in the United States. By 2035, 45 percent of US citizens are estimated to be diagnosed with some form of heart disease. The American Heart Association said that it would result in annual treatment costs in excess of USD 1 trillion. Millions of Americans take omega-3 fatty acids for supposed heart benefits. But the dosages are way below Vascepa’s potency.
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