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Executive Summary

Approval of Norwich Eaton's (ITALICS)Asacol (mesalamine) would require an additional placebo controlled comparative study to provide evidence that Asacol is effective for the induction and maintenance of remission of ulcerative colitis, FDA's Gastrointestinal Advisory Committee concluded at its Sept. 11 meeting. The advisory committee voted four to three against recommending approval of Asacol for induction of remission, maintenance therapy, or second-line treatment against ulcerative colitis. Asacol's active ingredient is the 5-aminosalicylic acid (5-ASA) component of sulfasalazine (Rowell's Rowasa). Norwich Eaton maintained that Asacol has a better safety profile than sulfasalazine because Asacol does not contain sulfapyridine, the acid believed to cause adverse effects in sulfasalazine. Norwich Eaton is seeking approval for Asacol for first-line therapy in the induction and maintenance of remission for ulcerative colitis. Some committee members, however, proposed that Asacol be approved for second-line therapy for those patients who are intolerant of sulfasalazine. "If it were possible to recommend this drug be approved for second-line induction of and maintenance of remission," Committee Chairman David Ransohoff suggested, "the efficacy data, even though they're not very strong, combined with the history of 5-ASA, might be enough to allow approval." Ransohoff added, however, that "if the drug is likely to be used . . . as a frontline drug, then I think that I [would go] against approval at the present time." The committee concluded that only one study, a placebo controlled study for induction of remission conducted at the Mayo Clinic, showed that Asacol is effective. The Mayo Clinic trial assessed the efficacy of oral 5-ASA (Asacol) in the treatment of mild to moderate ulcerative colitis in 87 patients randomized into three groups: 38 patients on 4.8 g/day of Asacol, considered the high dose, a low dose arm of 11 patients receiving 1.6 g/day and a placebo arm of 38 patients. A 74% improvement was found in patients receiving the high dose, K. W. Schroeder, MD, Mayo Clinic, reported, with 25% of the high dose group showing complete remission.

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