NEWS - Tocilizumab approved for RA in Europe

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Tocilizumab Approved for Rheumatoid Arthritis in Europe

January 23, 2009 — The European Commission has approved Roche's

first-in-class therapeutic tocilizumab (RoACTEMRA) for the treatment

of moderate-to-severe rheumatoid arthritis (RA). Tocilizumab is the

first interleukin 6 (IL-6) receptor–inhibiting monoclonal antibody

developed for the treatment of RA. It is indicated in combination with

methotrexate (MTX) for the treatment of adult patients with

moderate-to-severe RA who have either responded inadequately to or

were intolerant to therapy with other disease-modifying antirheumatic

drugs (DMARDs) or tumor necrosis factor-alpha (TNF-alpha) antagonists.

Reducing IL-6 reportedly relieves inflammation of the joints and some

systemic effects of RA.

The European Commission approved tocilizumab on the basis of results

from several phase 3 studies, including the Actemra versus

Methotrexate double-Blind Investigative Trial In mONotherapy

(AMBITION) and the RheumAtoiD ArthritIs Study in Anti-TNF FailurEs

(RADIATE), demonstrating that treatment with tocilizumab — either

alone or in combination with MTX or other DMARDs — significantly

reduced RA signs and symptoms compared with treatment with current

DMARDs alone, regardless of previous therapy or disease severity.

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Read the full article here:

http://www.medscape.com/viewarticle/587253

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