Sanofi-aventis has announced that its investigational once-daily oral drug teriflunomide, for the treatment of relapsing multiple sclerosis (RMS), has met the primary endpoint in its Phase III trial.
The trial results showed that teriflunomide significantly reduced the annualised relapse rate (ARR) in patients with RMS at two years compared to placebo.
Both the doses of teriflunomide, 7mg and 14mg, were well-tolerated with similar number of patients experiencing either treatment-emergent adverse events (TEAEs) or TEAEs resulting in treatment discontinuation in the treatment arms versus placebo.
The Phase III trial was a randomised, double-blind, two-year trial tyat involved 1,088 RMS patients worldwide, with Expanded Disability Status Scale (EDSS), having at least one relapse in the previous year or two relapses in the preceding two years.
The patients were randomised to receive a placebo or teriflunomide of 7mg or 14mg, once daily.
The primary endpoint of the study was annualised relapse rate, and the secondary endpoint was time to disability progression as measured by EDSS.
Multiple sclerosis is a chronic, progressively disabling disease, affecting about two million people worldwide.