FDA Advisory Committee recommends approval of Actemra for the treatment of rheumatoid arthritis

“We are pleased with the FDA advisory committee’s very positive recommendation for Actemra, which helps move this promising new therapy closer to becoming available for patients who suffer from the debilitating symptoms of RA,” said William M. Burns, CEO of Roche’s Pharmaceuticals Division. “Based on the compelling data presented, and this positive recommendation from the committee, we remain hopeful that the FDA will approve Actemra for the treatment of RA and provide a new option to patients who are not achieving adequate symptom relief with current therapies.”

The committee’s vote was made after Roche presented results from five Phase III clinical trials. The clinical development program evaluated the effects of Actemra on signs and symptoms of RA, physical function, progression of structural damage, and health-related quality of life. Of these five studies, three trials were conducted in patients with inadequate response to disease modifying anti-rheumatic drugs (DMARDs), one trial was conducted in patients who failed anti tumor necrosis factor (TNF) therapy and one monotherapy study comparing Actemra to methotrexate, a current standard of care, was also conducted.

Results of these studies demonstrated that treatment with Actemra, alone or combined with methotrexate or other DMARDs, significantly reduced RA symptoms regardless of previous therapy or disease severity, compared with current DMARDs.

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