FDA grants supplemental approval for ACTEMRA

Basel, 05 January 2011 - FDA grants supplemental approval for ACTEMRA. ACTEMRA now includes labeling for the inhibition and slowing of structural joint damage, improvement of physical function, and achievement of major clinical response in rheumatoid arthritis Roche today announced that the United States (U.S. Food and Drug Administration (FDA) has extended the ACTEMRA (tocilizumab, RoACTEMRA in the European Union ) label to include inhibition and slowing of structural joint damage, improvement of physical function, and achievement of major clinical response in adult patients with moderately to severely active rheumatoid arthritis (RA), when given in combination with methotrexate (MTX). The supplemental approval comes one year after initial U.S. approval and supports the efficacy of ACTEMRA in treating RA. RA is a chronic, progressive inflammatory disease of the joints and surrounding tissues that is associated with intense pain, irreversible joint destruction and systemic complications. Joint damage often begins early in the disease and can lead to permanent disability; therefore, inhibiting structural damage to patients? joints is a critical measure of the effectiveness of an RA treatment. The new U.S. license extension was based on positive data from the Phase III LITHE trial which demonstrated that patients receiving either dose of ACTEMRA (4 mg/kg or 8mg/kg) in combination with MTX had significantly less damage to their joints at one year, compared to patients in the control group.