Earlier this week in its annual report Aegerion Pharmaceuticals provided an update on its ongoing problems with the FDA and the Department of Justice. As previously reported here and on The Street and on CNBC, the company landed in hot water with the FDA last year after its CEO made a series of off-label statements on the CNBC Fast Money show. (The company’s only product, Juxtapid…
Justice Department Investigating Aegerion Over Marketing Of New Cholesterol Drug
January 9, 2014 by Leave a Comment
Aegerion Pharmaceuticals disclosed today that it is being investigated by the US Department of Justice over its marketing of Juxtapid (lomitapide). The drug was approved in December 2012 to help further lower cholesterol in patients with homozygous familial hypercholesterolemia. The drug costs $250,000 a year. The approval came with a box warning about the risk of hepatotoxicity and a strict Risk Evaluation…
FDA Approves Lomitapide For Homozygous Familial Hypercholesterolemia
December 24, 2012 by Leave a Comment
Aegerion Pharmaceuticals said today that the FDA had approved lomitapide (Juxtapid) to help further lower cholesterol in patients with homozygous familial hypercholesterolemia. The approval comes with a box warning about the risk of hepatotoxicity and a Risk Evaluation and Mitigation Strategy (REMS) Program which will require certification of health care providers and pharmacies before the drug…
FDA Reviewers Recommend Approval For Lomitapide For Homozygous Familial Hypercholesterolemia
October 17, 2012 by 2 Comments
The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13-2 to recommend approval of Aegerion Pharmaceuticals’ cholesterol-lowering drug lomitapide for use in patients with homozygous familial hypercholesterolemia (FH). The lopsided vote does not completely reflect the views of many of the panel members, who expressed considerable concern that the drug might be used in lower…
FDA Reviewers Raise No New Red Flags Over Lomitapide
October 15, 2012 by 1 Comment
FDA reviewers have raised no new concerns about lomitapide ahead of a Wednesday meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The FDA today released briefing documents that evaluate the new drug application (NDA) for lomitapide capsules, the microsomal triglyceride transfer protein (MTP) inhibitor from Aegerion Pharmaceuticals for use as an adjunct to a low-fat diet and…
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