Roche Holding AG (BASEL, Switzerland) announced that their alliance partner company Chugai Pharmaceutical Co, Ltd (TOKYO, Japan) has received approval in Japan for Actemra^® (tocilizumab) 200 mg administered as intravenous infusion for additional indications of rheumatoid arthritis (RA) including preventing structural damage of joints, polyarticular-course juvenile idiopathic arthritis (pJIA) and systemic-onset juvenile idiopathic arthritis (sJIA). Japan is the first market to gain access to Actemra for the treatment of RA. JIA is the collective term for diseases with unknown cause associated with symptoms in joints occurring in children aged <16. Though clinical findings of pJIA have many similarities to RA, sJIA is accompanied by systemic symptoms that include remittent fever; sJIA is considered a severe disease.

Actemra, the first of a new class of drug with a novel mechanism of action, is a humanized interleukin-6 receptor-inhibiting monoclonal antibody. The drug is the result of research collaboration by Chugai and it is being codeveloped globally with Chugai. An extensive clinical development program of 5 phase III trials evaluated the drug’s clinical findings. Thus far, 4 studies have been complete and have met their primary endpoints. A fifth trial, a 2-year study called LITHE (TociLIzumab safety and THE prevention of structural joint damage), is underway. The companies expect to report preliminary first-year data in later in 2008.

In Japan, Actemra was launched by Chugai in 2005 as a therapy for Castleman's disease.
The drug is awaiting approval in the US and Europe. The US FDA’s approval decision on Actemra could come as early as September 2008. Following approval in Europe, the drug will be copromoted by Chugai and Roche in the UK, France, and Germany.