Actemra approved in Japan to treat patients with rheumatoid arthritis

First approval for Actemra in rheumatoid arthritis worldwide

Roche announced today that their alliance partner company Chugai has received approval in Japan for the use of its innovative treatment, Actemra (tocilizumab), in patients suffering from rheumatoid arthritis (RA).

Actemra was approved by the Japanese authorities for the indication of rheumatoid arthritis (including prevention of structural damage of joints) and two forms of the disease that affect children, know as juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis.

Japan is the first market worldwide to get access to Actemra for the treatment of RA. The approval is based on compelling data from clinical trials conducted in Japan that showed Actemra was highly effective in controlling the symptoms and progression of this serious disease.

“Today’s approval represents a significant milestone for rheumatologists and patients in Japan. The Japanese authorities have recognized that Actemra is a breakthrough drug which addresses an unmet medical need for patients suffering from the debilitating effects of this disease” said William Burns, CEO Roche Pharmaceuticals Division.

Actemra is the first of a new class of drug with a novel mechanism of action that brings new hope to RA patients. It is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody, which works by suppressing the activity of IL-6, an important trigger of the inflammatory process. This novel mode of action reduces inflammation of the joints and relieves the systemic effects of RA.

Since 2005, Actemra has been marketed in Japan for the treatment of patients with a rare auto-immume condition known as Castleman’s disease. Actemra licence applications have also been filed for treatment of RA in the Unites States and the European Union in 2007, and are currently under review.

Rheumatoid Arthritis - A High Unmet Medical Need
Rheumatoid arthritis is a progressive autoimmune disease characterized by inflammation of the membrane lining in the joints throughout the body. This inflammation causes distortion of the joint and impaired function accompanied by pain, stiffness and swelling and ultimately leading to irreversible joint destruction and disability. In addition, the systemic symptoms of RA include fatigue, anaemia, osteoporosis and may contribute to shortening life expectancy by affecting major organ systems. Sadly after 10 years, less than 50% of patients can continue to work or function normally on a daily basis.

Juvenile idiopathic arthritis is the collective term for diseases with unknown cause associated with symptoms in joints occurring in children aged below sixteen. While clinical findings of pJIA have many similarities to rheumatoid arthritis, sJIA is accompanied by systemic symptoms, mostly remittent fever, and is considered a very severe disease.