Roche Submits Actemra Application

Swiss drugmaker Roche has submitted a biologics license application to the FDA seeking approval for Actemra to reduce the signs and symptoms in adults with moderate to severe rheumatoid arthritis (RA).

The submission is based on results from five international Phase III studies, which demonstrated Actemra (tocilizumab) as a monotherapy or in combination with disease-modifying anti-rheumatic drugs (DMARDs) significantly reduced the signs and symptoms of RA compared with DMARD therapies alone, according to Roche.

The company will file a marketing authorization application for the product with the European Medicines Agency in early December.