Rheumatoid Arthritis Drug Approved by the European Commission

The drug is given in combination with methotrexate (MTX) for the treatment of adult patients with moderate to severe RA who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease modifying antirheumatic drugs (DMARDs) or tumor necrosis factor (TNF) antagonists.

The European Commission's approval for RoACTEMRA was based on results from the largest clinical program undertaken for a biological reagent in RA including five multi-national Phase III studies, which demonstrated that treatment with RoACTEMRA -- alone or in combination with MTX or other DMARDs -- significantly reduced RA signs and symptoms, compared with current DMARDs alone.

While generally being well tolerated, the drug does have some potential side effects. The most common of these are upper respiratory tract infection, nasopharyngitis, headache, hypertension, and increases in liver enzymes. There may be increases in lipids (total cholesterol, LDL, HDL, or triglycerides) and decreases in neutrophils and platelets.

RoACTEMRA is the result of research collaboration between Chugai Pharmaceutical Company (Tokyo, Japan) and Roche (Basel, Switzerland). Roche will be managing worldwide marketing of the drug.

"Many patients suffering from rheumatoid arthritis fail to respond to any treatment and few actually achieve lasting remission, which is currently the ultimate goal of treatment for RA. The approval of RoACTEMRA offers new hope for patients suffering from the debilitating effects of rheumatoid arthritis" said William M. Burns, CEO of Roche's pharmaceuticals division. "Roche will work with the authorities in EU member countries to ensure that this groundbreaking therapy will be available to patients as quickly as possible."

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European Commission
Chugai Pharmaceutical Company
Roche