Roche receives FDA approval for SJIA drug
April 18th, 2011 // 1:53 pm @ jmpickett
Roche has received the US Food and Drug Administration (FDA) approval for Actemra to treat active systemic juvenile idiopathic arthritis (SJIA) in patients aged two years and older.
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.Roche receives FDA approval for SJIA drug
