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news.Roche has announced that the arthritis advisory committee of the FDA has recommended approval of Actemra, a novel interleukin-6 receptor-inhibiting monoclonal antibody, for reducing the signs and symptoms in adults with moderate to severe rheumatoid arthritis.
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The committee’s vote was made after Roche presented results from five Phase III clinical trials. The clinical development program was designed to evaluate the effects of Actemra on signs and symptoms of rheumatoid arthritis (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 therapy, and one monotherapy study comparing Actemra to methotrexate, a current standard of care, was also conducted.
Results of these studies have demonstrated that treatment with Actemra – alone or in combination with methotrexate or other DMARDs – significantly reduced RA signs and symptoms, regardless of previous therapy or disease severity, compared with current DMARDs.
Kenneth Bahrt, global medical director of autoimmunity for Roche, said: “Based on the strength of the data presented, and the positive recommendation by the committee, we are 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.”