Drug news
TEMSO study for Aubagio in Multiple Sclerosis is published in NEJM
The pivotal Phase III TEMSO study with investigational once-daily oral medication Aubagio (teriflunomide) from Sanofi/Genzyme is published in The New England Journal of Medicine (NEJM). Results showed that teriflunomide at the 14mg dosage significantly reduced the annual relapse rate, reduced disability progressions and improved several magnetic resonance imaging (MRI) measures of disease activity, including new or worsening brain lesions in relapsing, remitting Multiple Sclerosis. Teriflunomide has a well-characterized safety profile, with a similar proportion of trial participants reporting adverse events compared to placebo. Teriflunomide has been filed with the FDA in August of 2011 and the EMA filing is expected in the first quarter of 2012. see Randomized Trial of Oral Teriflunomide for Relapsing Multiple Sclerosis
Paul O'Connor, M.D., et al for the TEMSO Trial Group N Engl J Med 2011; 365:1293-1303 October 6, 2011.