FDA Advisory Committee recommends Xeljanz to treat ulcerative colitis.- Pfizer.

Pfizer announced a positive outcome from the FDA Gastrointestinal Drugs Advisory Committee (GIDAC) meeting which met to discuss Pfizer�s supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib), which is currently under review by the FDA, for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). The GIDAC voted on two dosing questions related to the use of the 10 mg twice-daily (BID) dose beyond the eight week induction period.

First, the Committee voted unanimously (15-0) in favor of the extension of the use of tofacitinib 10 mg BID from eight to 16 weeks of induction in adult patients who have not achieved adequate therapeutic benefit by Week 8. Second, the Committee voted unanimously (15-0) in favor of 10 mg BID as continuous maintenance treatment for adult patients with an inadequate response, loss of response or intolerance to tumor necrosis factor (TNF) blocker therapy.

The submitted sNDA for adult patients with moderately to severely active UC included a proposed dosing regimen of tofacitinib 10 mg BID for eight weeks of induction, followed by tofacitinib 5 mg BID for maintenance. It also included the proposed option to extend the induction period by an additional eight weeks (for a total of 16 weeks), as well as proposed consideration for the use of tofacitinib 10 mg BID for maintenance therapy in patients with an inadequate response, loss of response, or intolerance to TNF blocker therapy. The third question the Committee voted on related to a post-marketing efficacy study comparing a tofacitinib 10 mg BID continuous dosing regimen versus a regimen of tofacitinib 10 mg BID induction and 5 mg BID as maintenance in this patient population. The Committee voted 8-7 against conducting this study.