Roche has announced that the European Committee on Human Medicinal Products has given a positive recommendation for RoActemra, in combination with methotrexate, for the treatment of adult patients with moderate to severe rheumatoid arthritis (RA)


Patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease modifying anti-rheumatic drugs or tumor necrosis factor antagonists. In these patients, RoActemra can be given as monotherapy in cases of intolerance to methotrexate (MTX) or where continued treatment with MTX is inappropriate. RoActemra is said to be the first interleukin-6 receptor-inhibiting monoclonal antibody developed for the treatment of rheumatoid arthritis and a new therapy option to help tackle this serious disease.

The European Committee on Human Medicinal Products's positive opinion on RoActemra was based on results from five multinational phase III studies which demonstrated that treatment with RoActemra – alone or combination with MTX or other disease modifying anti-rheumatic drugs (DMARDs) – significantly reduced RA signs and symptoms, compared with current DMARDs alone. These benefits were regardless of previous therapy or disease severity.

William Burns, CEO of Roche's pharmaceuticals division, said: "Today's positive opinion by the European authorities for the approval of RoActemra for RA is an important step forward in the fight against this debilitating disease. Roche will work with the authorities to ensure that this groundbreaking therapy will be available to patients as quickly as possible."