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Roche’s Actemra gets “complete response” letter

Executive Summary

FDA's Sept. 18 "complete response" letter for Roche's rheumatoid arthritis biologic Actemra (tocilizumab) requests more details on labeling and manufacturing. Actemra would be the first IL-6 inhibitor to reach the U.S. market, if approved. Roche's pharmacovigilance plan, which could take the form of a Risk Evaluation and Mitigation Strategy, had eased the safety concerns of FDA's Arthritis Drugs Advisory Committee, which supported approval by a 10-1 vote in July (1"The Pink Sheet," Aug. 4, 2008, p. 11). No additional studies are requested and Roche is working with FDA to address questions and "define the path forward.

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