Roche said July 10th that biologic Actemra (tocilizumab), a humanized monoclonal antibody that works by a different mechanism than today's rheumatoid arthritis treatments, met its goals in a third international trial bringing the biologic drug closer to submission for regulatory approval.
Actema is the first biologic to inhibit the interleukin-6, or Il-6, receptor. IL-6 is considered an important mediator of the acute inflammatory response, and Actemra targets a new mechanism of action compared to existing biologic drugs, which are dominated by anti-TNFs.
Roche said the 24-week late-stage study conducted in 498 patients with difficult-to-treat rheumatoid arthritis showed a greater proportion of patients treated with Actemra plus methotrexate achieved a significant improvement in disease signs and symptoms.
Roche plans to file Actemra, developed by Japanese pharmaceutical company Chugai Pharmaceutical Co. which Roche controls, for regulatory approval in Europe and the U.S. by the end of 2007.
This was the third of five international late-stage trials that investigating Actemra's efficacy and safety. The drug has shown promising results in trials Japan.
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