Actemra Significantly Improves Rheumatoid Arthritis Symptoms; Goes to FDA for Approval

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Updated December 30, 2014.

Actemra (tocilizumab) is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody seeking FDA approval to treat rheumatoid arthritis. A biologics license application (BLA) for Actemra to reduce the signs and symptoms in adults with moderate to severe rheumatoid arthritis has been submitted to the U.S. Food and Drug Administration (FDA) by the drugmaker Roche. The BLA is based on results from 5 international Phase III studies that concluded Actemra as monotherapy or in combination with other disease-modifying anti-rheumatic drugs (DMARDs) -- such as methotrexate -- significantly reduced signs and symptoms of rheumatoid arthritis compared to the DMARD alone.

New data from the TOWARD study was presented at the American College of Rheumatology Annual Scientific Meeting which was held November 6-11, 2007 in Boston. In the TOWARD trial, 61 percent of patients taking Actemra plus a DMARD achieved 20 percent reduction in rheumatoid arthritis symptoms -- compared to to only 25 percent of patients in the control group (taking DMARDs alone). About 1 in 3 patients achieved clinical remission in the Actemra group. Overall, there were 1,216 patients at 130 trial sites in 18 countries involved in the TOWARD study. Another trial, known as the OPTION study involved 623 study participants. Read more from Roche, the maker of Actemra.

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Photo by Ron Hohenhaus (iStockphoto)
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