FDA approval for Aubagio(Sanofi/Genzyme) as a treatment for relapsing Multiple Sclerosis

Sanofi and its subsidiary Genzyme announced that the FDA has approved Aubagio (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of Multiple Sclerosis (MS). Aubagio has shown significant efficacy across key measures of MS disease activity,including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI.

The FDA approval was based on efficacy data from the TEMSO (Teriflunomide Multiple Sclerosis Oral)trial. In the Phase III TEMSO trial, Aubagio 14 mg significantly reduced the annualized relapse rate (p=0.0005) and the time to disability progression (p=0.0279) at two years versus placebo in patients with relapsing forms of multiple sclerosis. Aubagio 7 mg significantly reduced the annualized relapse rate (p=0.0002) in the trial. In MS clinical studies with Aubagio, the incidence of serious adverse events were similar among Aubagio and placebo treated patients.