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Investigational Oral Multiple Sclerosis Therapy Teriflunomide (Aubagio™(*)) Significantly Reduced Relapse Rate, Disability Progression and Disease Activity
Date:10/5/2011

nomide compared to placebo. No serious or opportunistic infections and no deaths occurred in trial participants treated with teriflunomide.  The proportion of participants who discontinued the study medication because of disease progression was significantly smaller in the group receiving the 14mg of teriflunomide than in the placebo group (p=0.02). Malignancies were reported in three participants in the placebo group and one in the teriflunomide 14mg group.

Teriflunomide adverse events were usually of mild to moderate intensity, managed with existing therapies and rarely led to treatment discontinuation. The most common were diarrhea, nausea, liver enzyme increases (that were mainly mild and asymptomatic with no dose effect) and mild hair thinning/decreased hair density. In general, diarrhea, nausea and alopecia, were mild to moderate, transient, and infrequently led to treatment discontinuation.

About Teriflunomide
Teriflunomide is an immunomodulatory, disease-modifying oral drug with anti-inflammatory properties, and is under investigation for the treatment of MS. Teriflunomide blocks the proliferation and functioning of activated T and B  lymphocytes - which are thought to be especially damaging in MS - by selectively and reversibly inhibiting a critical mitochondrial enzyme. Slowly dividing or resting lymphocytes are unaffected by teriflunomide, leaving the immune system's response to infection uncompromised. With nine years of continuous use in a Phase II extension, teriflunomide has the longest clinical experience of any investigational oral MS therapy. In addition to the TEMSO trial, two other Phase III trials, TOWER and TENERE, are ongoing in people with RMS. A Phase III study, TOPIC, is also underway in early MS or CIS (clinically isolated syndrome). Teriflunomide is also being evaluated as an adjunct therapy to interferon-beta in the Phase III TERACLES trial.

(*) Aubagio™ is the registered name submitted to
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SOURCE Sanofi; Genzyme
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