FDA Advisory Committee Recommends Approval of ACTEMRA(R) (tocilizumab) for the Treatment of Rheumatoid... (

FDA Advisory Committee Recommends Approval of ACTEMRA(R) (tocilizumab) for the Treatment of Rheumatoid Arthritis

Date:7/29/2008

- First interleukin-6 (IL-6) inhibitor to offer new therapeutic option for

rheumatoid arthritis -

NUTLEY, N.J., July 29 /PRNewswire/ -- Roche today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) by a near unanimous (10-1) vote recommended approval of ACTEMRA(R) (tocilizumab), a novel interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody, for reducing the signs and symptoms in adults with moderate to severe rheumatoid arthritis (RA).

"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," said Kenneth Bahrt, M.D., Global Medical Director, Autoimmunity, Roche. "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."

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 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 in combination with methotrexate or other DMARDs -- significantly reduced RA signs and symptoms, regardless of previous therapy or disease severity, compared with current DMARDs.

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