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Roche’s Actemra needs a REMS

Executive Summary

FDA announced Dec. 4 that a Risk Evaluation and Mitigation Strategy will be required of Roche's Actemra (tocilizumab), possibly pushing its launch back to 2010, and sending a message to other companies that any drug proposed with a comprehensive safety plan will most likely require a REMS. Roche had proposed an extensive post-marketing plan to monitor safety for the novel rheumatoid arthritis drug, which paved the way for a positive advisory committee review (1"The Pink Sheet," Aug. 4, 2008, p. 11). Additional non-clinical studies are also required. Roche expects to re-submit Actemra, which received a "complete response" letter in September, in the third quarter of 2009

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