European approval of paediatric license extension of teriflunomide (Aubagio) for treatment of relapsing remitting multiple sclerosis in patients aged 10 to 17 years
Approval for treatment is based on data from the Phase 3 TERIKIDS study (n=166) in which the primary endpoint was not statistically significant with numerically a lower risk (-34%) of clinical relapse for teriflunomide vs placebo (median time: 75.3 vs 39.1 weeks; HR; 0.66;P=0.29)
Source:
Biospace Inc.