Arthritis treatment approved in Japan
Japan has become the first market worldwide to gain access to newly approved drug used to treat rheumatoid arthritis.
Japan has become the first market worldwide to gain access to newly approved drug used to treat rheumatoid arthritis.
Roche's alliance partner company Chugai received approval in Japan to use Actemra (tocilizumab). The drug is used in prevent structural joint damage and two forms of the disease that affect children, know as juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis.
Actemra is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. The approval is based on 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 recognised 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 US and the European Union in 2007, and are currently under review.
Rheumatoid arthritis is a progressive autoimmune disease characterized by inflammation of the membrane lining in the joints throughout the body. Juvenile idiopathic arthritis is the collective term for diseases with unknown cause associated with symptoms in joints occurring in children aged below 16 years.