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Genzyme/Isis On Track To Submit Cholesterol Drug Mipomersen In 1H 2011

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Mipomersen, Genzyme/Isis Pharmaceuticals' second-generation antisense drug for severe high cholesterol, is four for four in terms of collecting positive outcomes in Phase III trials. But in addition to lowered cholesterol, patients in all of those studies had elevated liver enzymes, leaving open the question whether regulators will consider the side effect a manageable trade off for filling an unmet medical need

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