Roche applies for FDA approval of rheumatoid arthritis treatment

Roche has submitted a biologics license application (BLA) to US Food and Drug Administration (FDA) seeking approval for Actemra (tocilizumab) to reduce the signs and symptoms in adults with moderate to severe rheumatoid arthritis (RA).

The filing for Actemra in the US is an important milestone for Roche, and brings us another step closer to making this therapy available to the millions of patients in the USt who suffer from the pain and debilitating effects of rheumatoid arthritis,. said William M. Burns, CEO of the Pharmaceuticals Division at Roche.

Actemra is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA.

The BLA submission to the FDA is based on results from five international Phase III studies, which demonstrated Actemra as monotherapy or in combination with disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate significantly reduced the signs and symptoms of rheumatoid arthritis, as measured by ACR and disease activity score (DAS) remission rates, compared with DMARD therapies alone.

Actemra is the result of research collaboration with Japanese drug developer Chugai. Roche and Chugai are collaborating on a phase III clinical development programme in RA running outside Japan, with more than 4000 patients enrolled in 40 countries including several European countries and the US. In Japan, Chugai launched Actemra in June 2005 as a therapy for Castleman's disease and in April 2006 it filed for the additional indications of rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis.