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Genzyme/Isis’ Long-Awaited Kynamro NDA May Allay Liver Toxicity Fears

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Sanofi’s Genzyme business unit and Isis submitted an NDA for mipomersen, a first-in-class cholesterol-lowering antisense drug, in an orphan population of high-risk patients with a rare genetic cardiovascular disease – with an assist from three Phase III clinical trials from other, larger, high-risk populations, to help inform regulators.

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