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Enbrel, Remicade Anti-TNF Class Labeling Debated By FDA Advisory Cmte.

Executive Summary

Anti-TNF rheumatoid arthritis drug class labeling for tuberculosis risk was discussed by FDA's Arthritis Advisory Committee during an Aug. 17 safety update on Immunex' Enbrel (etanercept) and Centocor's Remicade (infliximab).

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TNF Inhibitors Should Carry Class Warnings For Lymphoma, CHF – FDA Cmte.

Tumor necrosis factor inhibitor labeling should carry class warnings for the risks of lymphoma and congestive heart failure, FDA's Arthritis Advisory Committee recommended March 4

TNF Inhibitors Should Carry Class Warnings For Lymphoma, CHF – FDA Cmte.

Tumor necrosis factor inhibitor labeling should carry class warnings for the risks of lymphoma and congestive heart failure, FDA's Arthritis Advisory Committee recommended March 4

TNF inhibitor safety review

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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