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Aegerion’s Lomitapide Gets Standard Review For Rare Genetic Cholesterol Disease

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Aegerion is preparing for an advisory committee meeting after submitting its LDL-C lowering oral drug lomitapide to FDA for patients with homozygous familial hypercholesterolemia. The NDA was submitted ahead of that for Isis/Genzyme’s injectable competitor, mipomersen.

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