Roche's RoACTEMRA EU Label Update Approved

Roche reported that its label expansion to its rheumatoid arthritis (RA) drug RoACTEMRA (tocilizumab) has been approved in the EU.

RoACTEMRA is a humanized anti-interleukin 6 (IL-6) receptor antagonist monoclonal antibody indicated as a monotherapy or as a combination treatment with MTX for moderate to severe RA in adults patients who are intolerant to or who have had inadequate response to previous therapy. The new approval allows the use of RoACTEMRA in patients with severe, active, and progressive RA who are methotrexate (MTX) treatment-naïve.

Sandra Horning, Head of Global Product Development and CMO at Roche, said, “RoACTEMRA is an effective biologic treatment for patients with early RA that may change the course of disease and reduce the likelihood of disability. As the first IL-6 receptor antagonist approved for early RA, RoACTEMRA addresses the need for alternative treatment options to anti-tumor-necrosis-factor (anti-TNF) therapies in this debilitating condition.”

Rheumatoid arthritis is an autoimmune disease characterized by the chronic inflammation of joints. Cartilage and bone are progressively damaged in affected patients, leading to worsening disability. The disease affects an estimated 40 million worldwide. Most patients depend on combination treatments that include MTX, the leading disease-modifying antirheumatic drug (DMARD).

The EU approval was supported by positive data from the Phase III FUNCTION study showing that the drug achieved a greater improvement in disease activity after 24 weeks of treatment. The drug also showed that RoACTEMRA treatment with or without MTX resulted in greater inhibition of structural joint damage versus treatment with MTX alone.

The approval marks the fifth update and label expansion to RoACTEMRA in the EU in three years.