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Sanofi gets CHMP nod for Aubagio NAS designation

June 29, 2013 1:24 AM UTC

EMA's CHMP said it now recommends that Aubagio teriflunomide from Sanofi (Euronext:SAN; NYSE:SNY), which is under review to treat relapsing-remitting multiple sclerosis (RRMS), be considered a new active substance (NAS). In March, the committee recommended approval of Aubagio without the NAS designation because teriflunomide is a metabolite of leflunomide, a generic rheumatoid arthritis drug. At Sanofi's request, CHMP re-examined the opinion and concluded that teriflunomide could be considered a NAS because of safety differences between teriflunomide and leflunomide.

The NAS designation entitles a sponsor to eight years of data exclusivity plus two years of market exclusivity starting on the date of marketing approval. Sanofi's Genzyme Corp. unit markets Aubagio, a dihydroorotate dehydrogenase (DHODH) inhibitor, in the U.S., Australia and Argentina to treat relapsing forms of MS (see BioCentury Extra, March 22). ...