Aegerion gets DOJ subpoena over marketing of cholesterol drug
(Reuters) – Aegerion Pharmaceuticals Inc said on Thursday that it received a subpoena from the U.S. Department of Justice, requesting documents related to the marketing and sale of its cholesterol drug Juxtapid in the United States. Juxtapid was approved by U.S. health regulators in December 2012 to treat patients with homozygous familial hypercholesterolemia (HoFH), a rare genetic disease that impairs the function of the receptor responsible for removing LDL-C or “bad” cholesterol from the body. Chief Executive Mark Beer had received a warning letter from the U.S. Food and Drug Administration in November over statements that the regulator said misleadingly suggested Juxtapid was safe and effective in decreasing cardiovascular events and could be used as a standalone therapy. The FDA asked that the company respond with a plan to show it would not use promotional material containing the misleading statements and a strategy to adopt corrective measures in the marketing of the drug.