Roche’s Actemra Postmarket Safety Plan May Obviate Need For REMS
Executive Summary
Roche may have staved off the imposition of a REMS for its rheumatoid arthritis candidate Actemra by proposing a robust pharmacovigilance of its own
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Roche’s Actemra needs a REMS
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
Roche’s Actemra needs a REMS
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
Roche’s Actemra gets “complete response” letter
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.