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FDA Advisory Committee Recommends Infliximab For Treatment Of Crohn's Disease MALVERN, PA -- May 29, 1998 -- The United States Food and Drug Administration’s gastrointestinal drugs advisory committee has voted unanimously to recommend approval of Centocor, Inc.’s infliximab, a novel monoclonal antibody for treatment of patients with moderate to severe Crohn's disease for whom conventional therapy is inadequate and for the treatment of Crohn's patients with draining fistulae. The committee's recommendation is not binding, and specifics of labelling and other details will be considered by the FDA in completing its expedited review of the application submitted by Centocor, Inc. on Dec. 30, 1997. Crohn's disease is a chronic, debilitating disorder characterised by inflammation of the gastrointestinal tract and complicated, in some patients, by fistulae -- painful channels that open between the bowel and the skin, mostly in the perianal area, causing drainage of mucous and/or fecal material. The committee reviewed data from two clinical trials of patients suffering from active and fistulizing Crohn's disease. In the initial study, 65 percent of patients treated with infliximab achieved a clinical response and 33 percent of patients went into remission within four weeks of treatment. Data from the second study indicated that approximately two-thirds of participants experienced closure of at least 50 percent of their enterocutaneous fistulae. If approved by the FDA, infliximab will be the first of a revolutionary class of agents to block activity of a key pro-inflammatory mediator called tumour necrosis factor alpha, or TNF-(alpha). Infliximab may work by binding to TNF-(alpha) on the cell membrane, neutralising TNF-(alpha) in the blood or destroying TNF-(alpha) producing cells. E-mail this page to a friend or colleague! To print, use this version