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ARTICLE | Clinical News

FDA GI panel backs Pfizer's Xeljanz for ulcerative colitis

March 9, 2018 6:36 PM UTC

FDA’s Gastrointestinal Drugs Advisory Committee voted unanimously in favor of approving twice-daily 10 mg Xeljanz tofacitinib from Pfizer Inc. (NYSE:PFE) to treat adults with moderately to severely active ulcerative colitis. The panel also voted 8-7 against recommending a post-marketing efficacy trial to compare a continuous twice-daily 10 mg Xeljanz regimen to induction at 10 mg twice daily followed by maintenance at 5 mg twice daily.

The committee voted 15-0 that safety and efficacy data supported twice-daily dosing with 10 mg Xeljanz for induction therapy for 16 weeks in patients who have not achieved adequate therapeutic benefit by week eight. It also voted 15-0 that safety and efficacy data supported continuous maintenance treatment with twice-daily 10 mg Xeljanz in patients with an inadequate response, loss of response or intolerance to tumor necrosis factor (TNF) inhibitor therapy...

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