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FDA panel backs Actemra

July 30, 2008 1:47 AM UTC

FDA's Arthritis Drugs Advisory Committee on Tuesday voted 10-1 to recommend approval of Actemra tocilizumab from Roche (SWX:ROG) to treat moderate to severe rheumatoid arthritis (RA) in adults. FDA and the panel agreed that Roche had demonstrated efficacy of the humanized mAb against interleukin-6 (IL-6) receptor.

Discussion focused on safety signals, including increased risk of infection, liver enzyme abnormalities and lipid parameter changes, which FDA said were comparable to those caused by TNF inhibitors approved for RA. Committee members expressed concern about suggestions from clinical trials that Actemra may be associated with an increased incidence of gastrointestinal perforations, although they also noted the increase may have been due to concommitant NSAID and corticosteroid use. The committee endorsed Roche's risk management plan, which includes continuation of ongoing open-label extension studies, as well as registry studies and collection of observational data from claims databases. ...