FDA approves Aubagio for MS

FDA approved an NDA late Wednesday from Sanofi (Euronext:SAN; NYSE:SNY) for once-daily oral Aubagio teriflunomide to treat relapsing forms of multiple sclerosis (MS). The dihydroorotate dehydrogenase (DHODH) inhibitor is the second oral MS drug approved in the U.S. The first, Gilenya fingolimod from Novartis AG (NYSE:NVS; SIX:NOVN), has seen limited uptake since its launch in 2010 because of cardiovascular safety issues. Gilenya is a sphingosine 1-phosphate (S1P) receptor agonist.

A potential third entrant in the oral space is BG-12 from Biogen Idec Inc. (NASDAQ:BIIB), for which an FDA decision is expected around year end. The product is a dimethyl fumarate that activates the nuclear factor (erythroid-derived 2)-like 2 ( NFE2L2; NRF2) pathway. ...