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FDA review raises safety concerns about mipomersen

from Forbes

An FDA review raises a number of potentially significant safety concerns about the cholesterol-lowering drug mipomersen. The review appeared ahead of a recent meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to evaluate Genzyme's new drug application for use of the drug as an adjunct to maximally tolerated lipid-lowering medications and diet to reduce LDL, apolipoprotein B, total cholesterol, non-high density lipoprotein-cholesterol and lipoprotein(a) in patients with homozygous familial hypercholesterolemia. Mipomersen is an antisense oligonucleotide inhibitor which targets apoB-100. more


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