Tuesday, March 26, 2013

Aubagio receives positive nod from EU CHMP, but denied NAS designation

The EMA CHMP has recommended approval for two relapsing remitting Multiple sclerosis treatment -  Aubagio (Teriflunomide, Sanofi) and Tecfidera( Dimethyl Fumarate, Biogen Idec).  CHMP's recommendation for Aubagio notes that the committee did not recommend that the
dihydroorotate dehydrogenase (DHODH) inhibitor receive new active substance (NAS) designation. The recommendation did not provide a reason. We believe the NAS deisgnation would have probably been denied because teriflunomide is not a novel NCE, but an active metabolite of leflunomide, which was approved by the FDA IN 1998 for treatment of rheumatoid arthritis. 
Sanofi intends to request a reexamination of the recommendation on NAS designation

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