Aubagio Approved for RRMS in Canada

Health Canada has approved Genzyme/Sanofi‘s Aubagio (teriflunomide) 14 mg as monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.

The approval was based on efficacy data from two Phase III trials, TEMSO (TEriflunomide Multiple Sclerosis Oral) and TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis). In the former trial, Aubagio 14 mg significantly reduced the annualized relapse rate and the time to disability progression at two years versus placebo in patients with RRMS. In the TOWER trial, Aubagio 14 mg significantly reduced the annualized relapse rate and the time to disability progression sustained for 12 weeks was statistically significantly reduced versus placebo in patients with RRMS.

New positive data from another Aubagio study, TOPIC, was presented at the 29th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark. The double-blind, multi-center trial enrolled 618 patients who had experienced a first acute or sub-acute, well-defined neurological event consistent with demyelination as well as onset of MS symptoms within 90 days of randomization, and MRI scan showing two or more lesions characteristic of MS. The two-year study was designed to assess whether early initiation of Aubagio in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack.

The TOPIC study found Aubagio 14 mg significantly reduced the risk of a new clinical relapse over the two-year study period. There was a 35% reduction among patients who received Aubagio14 mg compared to placebo.

Aubagio is approved in the U.S., Europe, Australia, Argentina, Chile, South Korea and Mexico for the treatment of relapsing forms of MS. Marketing applications for Aubagio are also under review by additional regulatory authorities globally.