According to Roche, the FDA’s decision was supported by the positive results from a randomized, double-blind, Phase III study which demonstrated that 85% of children with SJIA receiving Actemra experienced a 30% improvement in the signs and symptoms of SJIA and an absence of fever after 12 weeks of therapy, compared with 24% of children receiving placebo.
Moreover, in the trial, 71% of children treated with Actemra achieved a JIA ACR70 at week 12 compared with 8% of those receiving placebo.
Roche Global Product Development head and chief medical officer Hal Barron said Actemra offers a new option for this extremely difficult to treat disease.