2:42 PM
Mar 08, 2018
 |  BC Extra  |  Company News

FDA GI panel backs Xeljanz for UC

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.

Xeljanz, an oral pan-Janus kinase (JAK) inhibitor, is approved in the U.S. to treat rheumatoid arthritis and psoriatic arthritis. The product’s PDUFA date for the UC indication is in June.

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