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

 
• By Sue Sutter

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.

Lengthy post-marketing experience with Sanofi’s rheumatoid arthritis drug Arava (leflunomide) not only guided FDA’s safety evaluation of Aubagio (teriflunomide), it rendered unnecessary a Risk Evaluation and Mitigation Strategy for the new multiple sclerosis treatment.

Teriflunomide is the active and primary metabolite of leflunomide, which has been marketed in the U.S. for more than a decade. FDA’s safety evaluation of teriflunomide incorporated the entirety of leflunomide’s safety experience, importing the older drug’s risks to the new compound

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