FDA advisory panel votes against Vascepa approval expansion
An advisory panel of the US Food and Drug Administration has voted against the expansion of approval for Amarin Corporation Plc’s triglyceride-lowering drug Vascepa (icosapent ethyl).
The panel voted 9-2 against approval of the drug for patients who are at high risk of coronary heart disease and who also take a cholesterol-lowering statin such as Pfizer’s Lipitor (atorvastatin calcium).
The US FDA approved Vascepa capsules (formerly known as AMR101) back in July 2012 as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (very high triglycerides). Amarin had hoped to market the drug to a much broader patient population.
However, it “has not yet been proven” that Vascepa or any other medication that lowers blood fats, except statins, decreases cardiovascular risk, according to Dr David Cooke, FDA advisory panelist and clinical director of pediatric endocrinology at Johns Hopkins University School of Medicine.
The FDA does not have to follow its panel’s recommendation but typically does so. However, the regulatory body has suggested that the decision be withheld pending the results of an 8000-patient clinical trial currently being conducted by Amarin. These results are expected in late 2016.
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