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Aubagio Approval Reflects FDA’s Evolving View On Multiple Sclerosis Drugs

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Sanofi’s teriflunomide is indicated broadly for treating relapsing forms of MS. The claim marks a departure from previously approved MS drugs, in which the specific effects seen in clinical trials are described in the Indications section. FDA said the Aubagio claim more closely reflects how physicians actually use the drugs and represents a more flexible regulatory approach that enabled approval of a second, lower dose.


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