RoActemra Approved in Europe for Rheumatoid Arthritis

RoActemra (tocilizumab), has been approved in Europe to treat rheumatoid arthritis. RoActemra is known as Actemra outside of the European Union. RoActemra is the first interleukin-6 (IL-6) receptor inhibiting monoclonal antibody that has been developed to treat the disease. The drug is administered intravenously (IV). Roche, the drugmaker, has recommended RoActemra for patients with moderate to severe rheumatoid arthritis who have failed one or more disease-modifying anti-rheumatic drugs (DMARDs) or TNF blockers. It is recommended in combination with methotrexate but can be used alone (as monotherapy).

RoActemra is also approved in several other countries including Japan, India, and Switzerland. It is not yet approved in the United States. On July 29, 2008, the Arthritis Advisory Committee of the FDA voted 10-1 to recommend approval of Actemra, but the FDA has requested more information from Roche before it grants final approval.

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
• FDA Delays Approval of Actemra

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