Multiple Sclerosis Research Repository

Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202992Orig1s000StatR.pdf

-“In the examination of EDSS score change, which the determiantion of disability progression was based on, the data suggested no or little treatment difference at Week 48 and Week 108 (Table 8). The mean change in EDSS score for the placebo group was slightly better than both active treatments at Week 48 but slightly worse than the Teriflunomide 14mg at the Week 108.”

-“The trend of time to disability progression turned into opposite direction in the region of Americans, inwhich both groups of Teriflunomide observed more patients reaching progression than the placebo group (Table 19).”

-“The data showed that in the region of Americans, placebo-treated patients had almost no increase in EDSS scores in average, while both dose grops of Teriflunomide showed worsening measured by EDSS scores and number of patients who had disability progression…There appeared to have [been] no baseline imbalance.”

-“In the region of Americas, the placebo group had fewer patients reaching disability progression than either dose groups of Teriflunomide”

-“The evidence of effect of Teriflunomide in delaying the physical disability is not strong enough to allow a definitive conclusion…”