FDA advisory committee recommends approval of IL-6 inhibitor for RA

The Arthritis Advisory Committee of the U.S. Food and Drug Administration voted 10-1 on Tuesday to recommend the approval of an interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment of rheumatoid arthritis (RA) in adult patients with moderate to severe forms of the disease.

If ultimately accepted by the FDA, tocilizumab (Actemra, Roche) would become the first interleukin-6 (IL-6) receptor-inhibitor approved for use in the United States.

"The committee's overwhelmingly positive recommendation brings Actemra one step closer to becoming available to patients who suffer from the painful and debilitating symptoms associated with RA," the global medical director of autoimmunity at Roche, Kenneth Bahrt, MD, said in a press release. "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."

At the committee meeting, representatives from Roche presented the results of five Phase III clinical trials evaluating the effects of tocilizumab on the signs and symptoms of RA, progression of structural damage, health-related quality of life and physical function.

"Results of these studies demonstrated that treatment with Actemra – alone or in combination with methotrexate of other DMARDs [disease-modifying anti-rheumatoid drugs] – significantly reduced RA signs and symptoms, regardless of pervious therapy or disease severity, compared with current DMARDs," according to a Roche press release.

The clinical studies included more than 4,000 patients in 41 countries. Most of the patients were rheumatoid factor-positive, Caucasian and women, according to a meeting briefing document.

Three of the clinical trials included patients with who had an inadequate response to DMARDs. One trial consisted of patients who failed anti-tumor necrosis factor therapy and another study simply compared tocilizumab to methotrexate.

Serious adverse events found in the trials included hypersensitivity reactions, diverticular perforations and serious infections. Headache, nasopharyngitis and hypertension were among the most common adverse events, according to the press release.

The manufacturer is also conducting a 2-year study investigating the impact of tocilizumab on structural joint damage. The results of that study are expected for 2009.

Actemra gained approval for the treatment of Castleman's disease in Japan in 2005 and was approved for RA, systemic-onset juvenile idiopathic arthritis and juvenile idiopathic arthritis in Japan 3 months ago.

For more information:
www.fda.gov
www.rocheusa.com