Sanofi-Aventis has presented late-stage data on its oral treatment teriflunomide, showing that it successfully reduces relapses and is well tolerated in multiple sclerosis patients.
The Phase III data, which has been presented at the European Committee for Treatment and Research in Multiple Sclerosis meeting in Gothenburg, Sweden, showed that both doses of teriflunomide (7 and 14mg) significantly reduced annualised relapse rate by 31% versus placebo. Also the risk of disability progression (sustained for 12 weeks) was significantly reduced by 30% for the 14mg dose and by 24% for the 7mg dose.
Both doses of teriflunomide were well tolerated, though adverse events occurring at a higher rate in the teriflunomide groups were diarrhoea, nausea, alanine transferase increases that were mainly mild and asymptomatic with no dose effect and mild hair-thinning and hair loss. These rarely led to treatment discontinuation, Sanofi said.
The French drugmaker’s head of research, Marc Cluzel, said the results are “an important step forward in multiple sclerosis clinical research”. He added that teriflunomide represents “a new real hope to delivering an oral therapy to patients who live with this serious condition and are eager for new treatment options”.
