Roche Holding AG says that arthritis drug Actemra has proved successful in a phase III clinical study. Actemra helps relieve symptoms of rheumatoid arthritis in difficult-to-treat patients in a clinical study thus bringing it closer to regulatory approval.
The Radiate study was conducted over 24 weeks with 498 patients with difficult-to-treat RA. Actemra was given in combination with a standard treatment called methotrexate in patients who had an inadequate response to a relatively new type of drugs known as anti-tumor necrosis factor therapy, or anti-TNFs. The treatment showed a significant improvement in disease signs and symptoms.
Biologic Actemra (tocilizumab), a humanized monoclonal antibody works by a different mechanism than today's rheumatoid arthritis treatments. 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.
Sufferers of rheumatoid arthritis, or RA, begin to experience progressive joint damage early in the disease. The disease differs from what is popularly known as arthritis, typically associated with age-related joint pain; RA is a far more serious inflammatory disease that leads to destruction of cartilage and bone, and can lead to disability.
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 is the third of five international late-stage trials that are investigating Actemra's efficacy and safety. Roche plans to release results from one more this year, while data from the fifth study will become available at a later date.
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