FDA News

Roche's ACTEMRA for the Treatment of Rheumatoid Arthritis Awaits FDA Approval

(Nov 20, 2007)-- Roche announced the submission of a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval to market ACTEMRA (tocilizumab) to reduce the signs and symptoms in adults with moderate to severe rheumatoid arthritis (RA).

"The filing for ACTEMRA represents a significant milestone for Roche, and brings us another step closer to making this important therapy available to the millions of patients in the United States who suffer from the agonizing pain and debilitating effects associated with rheumatoid arthritis," said George Abercrombie, President and CEO, Hoffmann-La Roche Inc.

ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA. Research suggests that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, may reduce inflammation of the joints and relieve certain systemic effects of RA.

The BLA submission to the FDA is based on results from five international Phase III studies which demonstrated ACTEMRA as monotherapy or in combination with disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate significantly reduced the signs and symptoms of rheumatoid arthritis as measured by ACR -- as well as achieving disease activity score (DAS) remission -- compared to DMARD therapies alone. Furthermore, patients who had previously failed anti-tumor necrosis factor (anti-TNF) treatments also showed significant improvement in signs and symptoms of RA after treatment with ACTEMRA.

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