Actemra (tocilizumab) Recommended for Approval by FDA Advisory Committee

Thursday July 31, 2008

Actemra (tocilizumab), the first interleukin-6 receptor-inhibiting monoclonal antibody for the treatment of rheumatoid arthritis, has been recommended for approval by the FDA Arthritis Advisory Committee. The vote to approve was 10-1 -- nearly unanimous. Actemra is being recommended as a treatment to reduce the signs and symptoms of moderate to severe rheumatoid arthritis in adults.

The recommendation was based on the results of 5 Phase III clinical trials, according to its maker Roche. Actemra was evaluated for its effect on signs and symptoms of rheumatoid arthritis, physical function, progression of structural damage, and health-related quality of life. Three of the 5 trials involved patients with previous inadequate response to DMARDs (disease-modifying anti-rheumatic drugs), one study involved patients who failed treatment with TNF blockers, and one study compared Actemra to methotrexate. Results showed that treatment with Actemra alone or in combination with methotrexate significantly reduced rheumatoid arthritis symptoms compared with current available DMARDs. The FDA is not forced to follow the committee's recommendation for approval but usually does.

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