BioCentury
ARTICLE | Clinical News

Aubagio teriflunomide: Phase III data

June 4, 2012 7:00 AM UTC

Top-line data from the double-blind, international Phase III TOWER trial in 1,169 patients with relapsing MS showed that once-daily 7 and 14 mg oral Aubagio each met the primary endpoint of reducing ARR from baseline to an average of 2 years vs. placebo. Specifically, low-dose Aubagio reduced ARR by 22.3% vs. placebo (p=0.02), while high-dose Aubagio reduced the endpoint by 36.3% (p<0.0001). High-dose Aubagio also met the secondary endpoint of reducing the risk of 12-week sustained accumulation of disability as measured by EDSS scores vs. placebo (31.5% reduction, p=0.0442), while low-dose Aubagio missed the endpoint. Sanofi's Genzyme Corp. subsidiary said that the once-daily 14 mg dose of Aubagio is the proposed commercial dose. The most common adverse events were headache, elevations in liver alanine transaminase (ALT) levels, hair thinning, diarrhea, nausea and neutropenia. There were 3 deaths in the Aubagio arms due to motor vehicle accident, suicide and sepsis.

Last December, Sanofi reported top-line data from the Phase III TENERE trial in 324 patients with relapsing MS showing that low- and high-dose Aubagio each missed the primary endpoint of reducing the risk of treatment failure, defined as the occurrence of a confirmed relapse or permanent treatment discontinuation for any cause, vs. Rebif interferon beta-1a at week 48 (see BioCentury, Jan. 2). The pharma also previously reported that low- and high-dose Aubagio each met the primary endpoint of reducing ARR from baseline to 2 years vs. placebo in the Phase III TEMSO trial in the indication (see BioCentury, Sept. 6, 2010; Oct. 18, 2010 & Oct. 31, 2011). ...