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

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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.


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