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Aubagio Clinical Development

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

A timeline chronicling the development history of Sanofi’s teriflunomide.

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FDA Looked To Arava’s Safety Experience In Gauging Aubagio’s Risks

Agency’s assessment of teriflunomide for multiple sclerosis incorporated the known safety data for leflunomide, a chemically related drug with an extensive post-marketing record in rheumatoid arthritis. Despite hepatotoxicity and other safety concerns with the older drug, its clinical experience provided reassurance that Aubagio’s risks could be managed without a REMS.

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

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.

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

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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