Amarin’s Fish Oil Pill Fails to Win U.S. Panel’s Backing
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Amarin’s fish-oil pill Vascepa failed to win the backing of U.S. advisers to significantly expand its use for those with high levels of fat in their blood.
Amarin should complete a study on the drug’s ability to benefit the heart before an approval decision for patients with high triglycerides, a Food and Drug Administration advisory panel voted 9-2 today in Silver Spring, Maryland. The FDA is scheduled to decide whether to clear the drug for wider use by Dec. 20. The agency doesn’t have to follow the panel’s advice.