The U.S Food and Drug Administration voted against the expanded use of the Amarin fish oil drug. They ruled out that further study is needed before patients with heart diseases include it in their medications.
Vascepa is the only product of Amarin. It was approved by the FDA in July 2012 and had been used by people with very high presence of triglycerides. The latter is a measure of fat in the blood which is said to be at 500 milligrams per deciliter.
While Vascepa lowers cholesterol in the blood, the advisory panel who voted 9-2 against the use of the drug for patients who also drink choletrol-lowering statin, was still hesitant that it can reduce the risk of coronary heart disease or death.
Though the U.S. FDA is not obliged to take steps in accordance to what the advisory panels suggest, the department does so.
The fish oil drug is allowed to reduce cholesterol in patients who do not drink statins. However, Amarin’s aim to market it to a larger population, “has not yet been proven,” said Dr. David Cooke, clinical director of pediatric endocrinology at Johns Hopkins University School of Medicine and a panelist. Vascepa and other drugs that lower cholesterol, except for statins, are not yet confirmed to decrease cardiovascular risks.
Until the results of the clinical trial involving 8,000 patients comes out, the approval of the Vascepa’s use will be suspended. The results will be released by late 2016. The trial is to test whether Vascepa reduces the risk for cardiovascular accidents.
Amarin will “in all likelihood need to raise additional capital” just to fund operations until the results come out, said Raghuram Selvaraju, an analyst at Aegis Capital Corp to Reuters. He added that while the results “could still vindicate Amarin, we believe that moving to the sidelines is probably the most appropriate strategy at this juncture."
