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RoACTEMRA approved in Europe to treat patients suffering from Rheumatoid Arthritis


First in class therapy offers new treatment option to patients with moderate to severe form of the disease

Roche today announced that the European Commission has approved 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 either responded inadequately to, or who were intolerant to, previous therapy with one or more disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) 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 the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody developed for the treatment of RA and is a novel approach to help tackle this debilitating disease.

RA is a chronic, progressive inflammatory disease of the joints and surrounding tissues that is associated with intense pain, irreversible joint destruction and systemic complications such as fatigue and anemia. There are several key cytokines, or proteins, involved in the inflammatory process including tumor necrosis factor (TNF) alpha, interleukin-1 (IL-1) and interleukin-6 (IL-6). IL-6 has been identified as having a pivotal role in the inflammation process. The exact cause of RA is unknown and there is no cure currently available.

“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.”

The European Commission’s approval for RoACTEMRA was based on results from the largest clinical program undertaken by a biologic in RA including, five multi-national Phase III studies which demonstrated that treatment with RoACTEMRA – alone or combination with MTX or other DMARDs– significantly reduced RA signs and symptoms, compared with current DMARDs alone. These benefits were regardless of previous therapy or disease severity.

The approval in the EU follows earlier approvals for the product in several countries, including Japan, India and Switzerland.


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