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Panel Review Of Aegerion’s Lomitapide May Lead To Evolution Of Cholesterol Drug Approval Standards

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA will be using an upcoming advisory panel review of Aegerion Pharmaceuticals Inc.’s lomitapide to see if there is still support for traditional lipid endpoints in clinical trials of cholesterol drugs.

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Cholesterol Endpoints Draw Scrutiny At HoFH Panels

The Metabolic and Endocrinologic Advisory Committee accepts LDL lowering as endpoint for homozygous hypercholesterolemia drugs, backing approval of Aegerion’s lomitapide by 13-2 and Genzyme’s mipomersen by 9-6, but hones in on the need for better surrogates for cardiovascular morbidity and mortality.

REMS Targeting Off-Label Use Helps Aegerion’s Lomitapide Clear FDA Panel

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee votes 13-2 that Aegerion’s lomitapide should be approved for homozygous familial hypercholesterolemia despite serious hepatic and other risks as long as every effort is made to prevent off-label use.

Mipomersen REMS Would Rely on Education, Not Prescribing Restrictions, To Address Hepatotoxicity

REMS will include a prescription form that has prescribers attest that the prescription is medically appropriate and that they will monitor hepatotoxicity biomarkers, according to FDA and Genzyme briefing materials for an Oct. 18 Metabolic and Endocrinologic Drugs Advisory Committee.

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