Pfizer declares optimistic result of FDA Advisory Committee Meeting on XELJANZ for UC

Pfizer declared optimistic outcome from U.S FDA‘s Gastrointestinal Drugs Advisory Committee (GIDAC) meeting.  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.

Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development said “If approved, tofacitinib will be the first Janus kinase inhibitor and the first oral therapy for adults living with moderately to severely active ulcerative colitis. We look forward to working with the FDA as it completes the review of our pending application.”

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.