ARTICLE | Clinical News

Actemra tocilizumab regulatory update

January 18, 2010 8:00 AM UTC

Roche and its Genentech Inc. unit said FDA approved a BLA for Actemra tocilizumab to treat moderate to severe rheumatoid arthritis in patients who have had an inadequate response to tumor necrosis factor (TNF) antagonists. The label includes a boxed warning concerning the risk of serious infection associated with use of Actemra, and the approval comes with a risk evaluation and mitigation strategy (REMS) on monitoring patients for liver and/or gastrointestinal side effects. FDA also will require the company to conduct a postmarketing trial to evaluate Actemra's long-term cardiovascular safety. ...