Genzyme, a Sanofi Company, has announced that the Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has issued a positive opinion regarding the approval of once-daily, oral Aubagio ( Teriflunomide ) for the treatment of adult patients with relapsing-remitting multiple sclerosis.

The CHMP did not recommend that Aubagio receive a new active substance ( NAS ) designation.

Teriflunomide is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Teriflunomide is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system ( CNS ).


Aubagio is approved to treat relapsing multiple sclerosis in the United States and Australia.

Aubagio is a once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis. Aubagio 14 mg has shown significant efficacy across key measures of multiple sclerosis disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI.

The Aubagio U.S. label includes a boxed warning citing the risk of hepatotoxicity and, teratogenicity ( based on animal data ).

In multiple sclerosis clinical studies with Aubagio, the incidence of serious adverse events were similar among Aubagio and placebo-treated patients. The most common adverse events associated with Aubagio in multiple sclerosis patients included increased ALT levels, alopecia, diarrhea, influenza, nausea and paresthesia.
Teriflunomide is the principal active metabolite of Leflunomide, which is indicated in the U.S. and Europe for the treatment of rheumatoid arthritis. Severe liver injury including fatal liver failure has been reported in patients treated with Leflunomide.

Aubagio is contraindicated in pregnant women and women of childbearing potential who are not using reliable contraception.

Aubagio is supported by a clinical program with more than 5,000 trial participants in 36 countries. Some patients in extension trials have been treated for up to 10 years.
The EU Aubagio submission includes efficacy data from the TOWER ( Teriflunomide Oral in people With relapsing remitting multiplE sclerosis ) and TEMSO ( Teriflunomide Multiple Sclerosis Oral ) trials.

Source: Genzyme, 2013

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