Singapore, April 16, 2008: Tokyo-based Chugai Pharmaceutical said the humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody, Actemra is approved by the Japanese Ministry of Health, Labor and Welfare for additional indications of rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis (pJIA) and systemic-onset juvenile idiopathic arthritis (sJIA).

 

Actemra is marketed in Japan for treating Castleman's disease since June 2005.

 

According to Chugai pharma, Actemra is the first antibody drug originating from Japan. Chugai in collaboration with Osaka University created Actemra, utilizing genetic recombinant technology to produce a monoclonal antibody against the anti-IL6 receptor. It works by inhibiting biological activity of IL-6 through competitively blocking the binding of IL-6 to its receptor.

 

Based on the clinical studies conducted in Japan, Chugai filed the application in April 2006, with phase I, phase II and two phase III studies for rheumatoid arthritis, phase III study for pJIA, and phase II and phase III studies for sJIA, together with efficacy and safety data of their extension studies.