Drug Cleared for Treating Moderate to Severe Rheumatoid Arthritis

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Roche has received marketing clearance for Actemra (tocilizumab) as a treatment for moderate to severe active rheumatoid arthritis (RA) in adults who have had an inadequate response to one or more treatments that block tumor necrosis factor.

Tocilizumab, which is a monoclonal antibody, works by blocking interleukin-6, a key cytokine involved in inflammation and is overabundant in RA patients. The drug may be used alone or in combination with methotrexate or other disease-modifying anti-rheumatic drugs. The drug is approved for once-monthly IV administration.

The Actemra clinical development program included five Phase 3 clinical trials and enrolled more than 4,000 subjects with RA in the United States and 40 other countries.

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