FRIDAY, Nov. 15, 2019 (HealthDay News) — 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.
Drug maker Amarin is seeking FDA approval for the use of Vascepa in patients who have lower blood fat levels but still have a risk of heart problems, despite taking cholesterol-lowering statins. A month’s supply of Vascepa costs roughly $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 heart problems 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 Dr. Jack Yanovski, a hormone specialist at the U.S. National Institutes of Health.
But Phillip Posner, the patient representative on the panel, noted that, “”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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