Genentech announced that the FDA has expanded the approved indication for Actemra (tocilizumab injection) for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). Actemra can be used both alone as a single-agent therapy and in combination with methotrexate (MTX) or other DMARDs.

The expanded indication is based on efficacy and safety data from Phase 3 trials which were pereviously available, post-marketing safety data since its approval in 2010, as well as data from other clinical studies, including those evaluating Actemra in a real-world setting.

Actemra, a humanized IL-6 receptor-inhibiting monoclonal antibody, is already indicated to treat moderately to severe active rheumatoid arthritis in adult patients after an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

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