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Amgen Kineret demonstrates efficacy

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA Arthritis Advisory Committee decides Aug. 16 in a 6 to 2 vote that Amgen's rheumatoid arthritis agent Kineret (anakinra) demonstrated efficacy, but says efficacy is "modest" in comparison to methotrexate. An interim analysis of 506 patients found a higher response rate for combo therapy with anakinra plus methotrexate vs. methotrexate alone. Based on results from an open-label study showing a higher rate of infection in patients receiving anakinra plus Immunex' Enbrel (etanercept), the committee recommended that anakinra labeling should have a strong warning against use with TNF-inhibitors, pending results of a double-blind safety trial with etanercept
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