FDA panel: Expand use of fish oil drug Vascepa
Approved use of the prescription-strength fish oil drug Vascepa should be widened to include more patients at risk for heart attack and stroke, a U.S. Food and Drug Administration advisory panel recommended Thursday.
Vascepa is currently approved for patients with extremely high levels of triglycerides, the Associated Press reported. Drug maker Amarin is seeking FDA approval for the use of Vascepa in patients who have lower triglycerides but still have a risk for cardiovascular events, despite taking statins. A month's supply of Vascepa costs approximately $300.
The FDA panel unanimously voted Thursday in favor of expanded use of Vascepa. Their decision was based on research showing that the drug can reduce rates of dangerous cardiovascular events in high-risk patients, the AP reported.
"There is no doubt this drug could benefit a substantial portion of the U.S. population and meet an unmet need," said panel member Jack Yanovski, M.D., a hormone specialist at the U.S. National Institutes of Health. But Phillip Posner, the patient representative on the panel, noted, "I do not want to see this become what I call cardio candy."
The FDA, which is not required to follow the panel's recommendation but typically does, is expected to make a decision by the end of the year, the AP reported.
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