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GEN News Highlights : Sep 13, 2012

FDA Approves Genzyme's Multiple Sclerosis Drug

FDA approved Genzyme’s immunomodulator Aubagio® (teriflunomide) for the once-daily oral treatment of relapsing forms of multiple sclerosis. Clearance in the U.S. was based on data from the TEMSO study, which showed that compared with placebo, treatment using Aubagio significantly reduced the annualized relapse rate and time to disability progression at two years. Regulatory review of teriflunomide is currently in progress in Europe.

The Aubagio clinical development program is ongoing, and involves over 5,000 patients in 36 countries, which Genzyme says is among the largest programs for any MS therapy. Some patients have already been treated with the drug for over 10 years.

The Aubagio label includes a warning citing the risk of hepatotoxicity and teratogenicity, based on animal data. However, the label has been informed by data on the marketed rheumatoid arthritis drug leflunomide, for which teriflunomide is the principal active metabolite.