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ARTICLE | Clinical News

Actemra regulatory update

February 27, 2012 8:00 AM UTC

FDA accepted for review an sBLA from Roche's Genentech Inc. unit to update the label for Actemra tocilizumab to include treatment of moderate to severe active rheumatoid arthritis in patients who have responded to, or who were intolerant to, previous therapy with >=1 DMARD. The PDUFA date is in October. The current indication is to treat patients with moderate to severe active RA who had an inadequate response to >=1 tumor necrosis factor (TNF) antagonist therapies. ...