Roche Plans Actemra Response for Third Quarter

Roche has detailed the preclinical data the FDA requested in its complete response letter for Actemra, a humanized anti-human interleukin-6 receptor antibody. The requirements for the additional preclinical data and a risk evaluation and mitigation strategy are the only items delaying approval of Actemra (tocilizumab) for the treatment of rheumatoid arthritis. Roche said it plans to submit its complete response in the third quarter.
Washington Drug Letter