CardioExchange Archive

December 26th, 2012

FDA Approves Lomitapide for Homozygous Familial Hypercholesterolemia

Larry Husten, PHD

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 can be […]

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October 18th, 2012

FDA Reviewers Recommend Approval of Lomitapide for Homozygous Familial Hypercholesterolemia

Larry Husten, PHD

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 13-2 on Wednesday 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 […]

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October 15th, 2012

FDA Reviewers Raise No New Red Flags Over Lomitapide

Larry Husten, PHD

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. It’s intended for use as an adjunct to a […]

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