Actemra(R), A Humanized Anti-Human IL-6 Receptor Monoclonal Antibody, Filed For Rheumatoid Arthritis In Japan

Chugai Pharmaceutical Co., Ltd. and F. Hoffmann-La Roche Ltd. announced today that the humanized anti-human IL-6 (interleukin-6) receptor monoclonal antibody, Actemra(R) [ generic name: tocilizumab (genetical recombination) ] was filed for the additional indication of rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis, to the Japanese Ministry of Health, Labour and Welfare.


Rheumatoid arthritis is a systemic inflammatory disease in which the cause is unknown. The main symptoms are multiple joint inflammation and progressive joint damage. In Japan, it is estimated that approximately 330 thousand patients are undergoing treatment. Since the majority of patients are females in their 40s and 50s, the disease is causing serious psychological and social problems not only for the patients but also for their families, and a measure to counter the disease is seriously needed. Systemic-onset juvenile idiopathic arthritis is one form of rheumatoid arthritis in children, and it is estimated that there are approximately 1,700 patients in Japan*. The main symptoms are joint involvement, remittent fever and rheumatoid rash. Patients are often forced to spend a long time fighting against the disease, causing various difficulties in school life and continuing into adulthood for employment.


Actemra(R), created by Chugai in collaboration with Osaka University, utilizes genetic recombinant technology to produce monoclonal antibody from mouse anti-IL-6 receptor monoclonal antibody. It works by inhibiting IL-6 biological activity through competitively blocking the binding of IL-6 to its receptor. Chugai filed the application with the two phase III studies conducted in Japan to gather data on efficacy and safety.


Actemra(R) was launched in June 2005 in Japan as a therapy for Castleman's disease**, following approval in April, and is now in preparation for filing the additional indication of rheumatoid arthritis. Outside of Japan, phase III clinical trials in rheumatoid arthritis are going on in 41 countries worldwide including co-development between Chugai and Roche, and Roche is planning to file the application in Europe and in the US in 2007.


* Estimated by using the incidence and prevalence rate derived from a field survey on "Medical Care of Juvenile Idiopathic Arthritis and Improvement of Quality of Life, 2001," combining with the population statistics of 2003 (Ministry of Health, Labour and Welfare).


** The approved indication is "improvement of various symptoms (e.g. general malaise) and laboratory findings (e.g. increased C-reactive protein, fibrinogen, and erythrocyte sedimentation rate, decreased haemoglobin and albumin) associated with Castleman's disease."


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