FDA Delays Approval of Arthritis Drug Actemra

The FDA has requested more information from Roche, the developer of Actemra (tocilizumab), before it grants final approval for the drug. Five phase III studies have demonstrated that Actemra - alone or in combination with methotrexate or other DMARDs (disease modifying anti-rheumatic drugs) - significantly reduced the signs and symptoms of rheumatoid arthritis, regardless of previous therapy or disease severity when compared with DMARDs alone. On July 29, 2008, the Arthritis Advisory Committee of the FDA voted 10-1 to recommend approval of Actemra.

The request for additional information by the FDA does not involve safety or efficacy (effectiveness) issues -- and additional studies are not required. The additional documentation requested is related to the manufacturing of Actemra and certain other components such as final labeling. Roche has said it is committed to working with the FDA to secure approval so the drug can be made available to patients.

Related Resources:

• Actemra - What You Should Know
• What Is a Monoclonal Antibody?
• Actemra for RA - Trial Results Successful
• Actemra Recommended for Approval by FDA Advisory Committee

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