FDA advisory panel gives unanimous support for use of Xeljanz in UC

There was good news for Pfizer (NYSE: PFE) last week, which announced a positive outcome from the US Food and Drug Administration Gastrointestinal Drugs Advisory Committee (GIDAC) meeting on an already blockbuster drug, sending the pharma giant’s shares up 2%.

The GIDAC 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 10mg 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 10mg 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 10mg BID as continuous maintenance treatment for adult patients with an inadequate response, loss of response or intolerance to tumor necrosis factor (TNF) blocker therapy.