Sanofi-Aventis: RMS drug meets primary endpoint in phase-3 study
PARIS An investigational relapsing multiple sclerosis drug significantly reduced annualized relapse rate in a late-stage clinical trial.
Sanofi-Aventis said its once-daily oral drug teriflunomide, which was tested as a monotherapy, reduced annualized relapse rate at two years versus placebo in patients with RMS, thus achieving the primary endpoint in the TEMSO phase-3 trial. TEMSO was a two-year randomized, double-blind, placebo controlled study including 1,088 RMS patients worldwide, ages 18 to 55 years, with at least one relapse over the previous year or at least two relapses over the preceding two years. Patients were randomized to placebo or teriflunomide, 7-mg or 14-mg, once daily.
Both the 7-mg and 14-mg doses of teriflunomide were well tolerated, Sanofi-Aventis noted.