Actemra gets advisory committee review
Executive Summary
Roche's Actemra (tocilizumab) will be evaluated by FDA's Arthritis Drugs Advisory Committee July 29. The rheumatoid arthritis candidate has a September user fee date, and if approved would be the first interleukin-6 receptor inhibitor approved for treatment of moderately to severely active rheumatoid arthritis in adults. Roche is seeking approval as monotherapy and in combination with disease-altering antirheumatic drugs