FDA Summary Review (NDA 204063/S-10: Tecfidera/dimethyl fumarate
-There was no statistically significant effect on disability progression
-Table 3: Clinical and MRI Results of Study 2:
-Proportion with disability progression: 1) Tecfidera 240 mg BID: 13%; Placebo: 17%; p-value:
0.25 (not statistically significant)
-relative risk reduction: 1)Tecfidera 240 mg BID: 21%; 2) Placebo: not listed; p-value: not listed
-”Placebo-Controlled Phase 3 Study of Oral BG-12 for Relapsing Multiple Sclerosis” by Ralf Gold MD et al (DEFINE study):
-confirmed progression of disability at 2 yr: placebo 27%; twice-daily BG-12: 16% (*data were available for 409 patients in this group; thrice-daily BG-12: 18%; hazard ratio vs placebo: twice daily BG-12: 0.62 (p = 0.005) (statistically significant); thrice-daily BG-12: 0.66 (p = 0.01)
-As compared with placebo, BG-12 reduce the risk of confirmed progression of disability that was sustained for 12 weeks by 38% over the 2-year study period in the twice-daily BG-12 group (p = 0.005) and by 34% in the thrice-daily BG-12 group (p = 0.01)
-”Placebo-Controlled Phase 3 Study of Oral BG-12 or Glatiramer in Multiple Sclerosis” by Robert J Fox, MD et al (CONFIRM study)
-Reductions in disability progression with twice-daily BG-12, thrice-daily BG-12, and glatiramer acetate versus placebo were not significant
-In a preplanned sensitivity analysis, 24-week confirmed disability progression was not significantly reduced versus placebo in the twice-daily BG-12, thrice-daily BG-12, and glatiramer acetate groups
-time to disability progression when comparing twice-daily BG-12 and thrice-daily BG-12 with glatiramer acetate:.(twice daily BG-12 v glatiramer acetate: p = 0.44) (not statistically significant) and (thrice-daily BG-12 v glatiramer acetate: p = 0.37) (not statistically significant)
-…neither BG-12 (at either dose) nor glatiramer acetate had a significant effect on disability progression in the CONFIRM study
Multiple Sclerosis Research Repository 