On Thursday, March 8, 2018 Gastrointestinal Drugs Advisory Committee (GIDAC) discussed a supplemental new drug application (sNDA) for Xeljanz (tofacitinib) tablets, by Pfizer Inc. (Pfizer), which proposed use for the treatment of adults with moderately to severely active ulcerative colitis with an inadequate response, loss of response or intolerance to conventional therapies [corticosteroids, azathioprine (AZA), 6-mercaptopurine (6-MP)] or tumor necrosis factor (TNF) blocker therapy.

The Committee agreed unanimously (15 of 15 members) with Pfizer’s proposed 10 mg twice-daily (BID) dosing as extended induction therapy for a total of 16 weeks in patients who have not achieved adequate therapeutic benefit by Week 8.

The Committee agreed unanimously (15 of 15 members) with Pfizer’s proposed 10 mg BID dosing as an option for continuous maintenance treatment for patients with a history of inadequate response, loss of response, or intolerance to TNF blocker therapy (TNF failures).

The Committee split its vote, with 8 members voting against and 7 members voting in favor, on requiring that Pfizer conduct a post-marketing efficacy trial in the population of TNF failures to compare the 10 mg BID continuous dosing regimen to a regimen of 10 mg induction and 5mg BID as maintenance.