EC Approves Roche’s RoActemra for Treating Active Systemic Juvenile Idiopathic Arthritis

Phase III study showed 85% of treated children with active disease achieved sJIA ACR30.

The EC has approved Roche’s RoActemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients aged two years and over who haven’t responded adequately to therapy with NSAIDs and systemic corticosteroids. The new approval covers use of RoActemra either alone or in combination with methotrexate. The IL-6 receptor inhibitor antibody is already marketed in the U.S. (as Actemra) and Europe for the treatment of rheumatoid arthritis in adult patients who haven’t responded to or are intolerant to DMARDs and TNF inhibitors. FDA approval of Actemra for treating sJIA was granted in April.

European clearance for the sJIA indication was based on data from the 112-patient Phase III Tender study, in children aged 2–17 years with active sJIA who could not tolerate or didn’t respond well to NSAID and systemic corticosteroid therapy. The results showed that that 85% of participants who received RoActemra experienced a 30% improvement in the signs and symptoms of disease (measured as JIA ACR30), and an absence of fever after 12 weeks of therapy. Equivalent improvements were demonstrated in just 24% of placebo-treated children. RoActemra therapy also led to 71% of patients achieving JIA ACR70 at week 12, compared with 8% of placebo-treated patients.

Actemra/RoActemra has been developed by Roche and its Chugai business. Since its first approval in Japan for the treatment of Castleman disease in 2005, the drug has been cleared in various markets worldwide for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic-onset juvenile idiopathic arthritis. Roche reported global Actemra/RoActemra sales of CHF 277 million (about $354 million) in the first half of 2011, up 99% (in local currencies) on the equivalent 2010 period.