The FDA has approved Actemra (tocilizumab, from Roche) for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Actemra is an interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody indicated for once monthly administration as monotherapy or in combination with methotrexate or other disease modifying anti-rheumatic drugs (DMARDs).

This approval was based on data from five Phase 3, multi-national clinical trials (RADIATE, OPTION, TOWARD, AMBITION, and LITHE) involving more than 4,000 patients. The studies showed Actemra, alone or in combination with methotrexate or other DMARDs, significantly reduced the signs and symptoms of rheumatoid arthritis compared with DMARDs alone.

Actemra is expected to be available the week of January 18, 2010.

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