FDA: Aegerion Pharmaceuticals, Inc. Drug Cuts Cholesterol but Has Liver Safety Risk
Published: Oct 15, 2012
Aegerion Pharmaceuticals Inc. (AEGR) rose in early trading after a U.S. regulatory staff report said the company’s plan to manage risk associated with its drug supports approval in adults with the most life-threatening forms of severely high cholesterol who have limited treatment options. Aegerion gained 14 percent to $18.14 at 9:02 a.m. New York time after the Food and Drug Administration staff report today on lomitapide. The report was released prior to an advisory panel meeting on Oct. 17. The agency is scheduled to make a final decision on the treatment, Cambridge, Massachusetts-based Aegerion’s lead product candidate, by the end of December. The once-daily pill aims to treat a genetic condition known as familial hypercholesterolemia that causes abnormalities in liver cells responsible for clearing LDL, or low density lipoprotein, particles from the blood.