TNF inhibitor safety review
Executive Summary
FDA may hold an advisory committee review investigating the potential link between tumor necrosis factor inhibitors (including Amgen's Enbrel, Centocor's Remicade and Abbott's Humira) and lymphoma. "There's been no formal announcement about the March review, but we have had some discussions with the FDA," Amgen Exec VP-R&D Roger Perlmutter, MD, said during a Jan. 23 earnings call. "As we understand it, the focus is on lymphoma and concerns for the TNF inhibitors." Amgen has "prepared a large briefing document. We're looking forward to reviewing it with the FDA." An Arthritis Drugs Advisory Committee meeting is tentatively scheduled for March 4 and 5. The panel previously reviewed immune disorders associated with Remicade and Enbrel (1"The Pink Sheet" Aug. 20, 2001, p. 6)...
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