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Roche RA Drug Approved in Europe

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Roche received approval from the European Commission for RoActemra (tocilizumab, known as Actemra outside of the EU), to treat patients with rheumatoid arthritis (RA). RoActemra, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderate to severe RA who have not responded to, or were intolerant of previous therapy with one or more disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. RoActemra is the first interleukin-6 receptor-inhibiting monoclonal antibody developed for the treatment of RA and represents a new treatment approach to the disease.

The approval was based on results from five multi-national Phase III studies demonstrating that treatment with RoActemra, alone or combination with MTX or other DMARDs, significantly reduced RA signs and symptoms, compared with current DMARDs alone. RoActemra was previously approved in several countries, including Japan, India and Switzerland.

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