Pfizer Inc (NYSE:PFE) reported a positive outcome from U.S. FDA Gastrointestinal Drugs Advisory Committee meeting. The GIDAC met to talk Pfizer’s sNDA for XELJANZ®, which is currently under evaluation by the FDA, for the cure of adult people with moderate-to-severe active ulcerative colitis.
Michael Corbo, the Chief Development Officer of Inflammation & Immunology at Pfizer Global Product Development, expressed that today’s discussion underlined the considerable unmet need that prevails for people struggling with ulcerative colitis, an ailment that is often weakening and difficult to control. They are encouraged about the promising result of today’s GIDAC meeting. If permitted, tofacitinib will be the initial Janus kinase inhibitor and the preliminary oral therapy for people living with moderate-to-severe active ulcerative colitis. They look forward to associating with the FDA as it closes the review of their pending application.
The GIDAC nominated on two dosing questions linked to the use of the 10 mg BID dose beyond the 8-week induction period. First, the Committee selected unanimously in favor of the extension of the application of tofacitinib 10 mg BID from 8 to 16 weeks of induction in adult people who have not recorded adequate therapeutic advantage by Week 8. Second, the Committee backed unanimously in favor of 10mg BID as continuous maintenance therapy for adult people with a loss of response, inadequate response or intolerance to TNF blocker therapy.
The filed sNDA for adult people with moderate-to-severe active UC comprised a proposed dosing plan of tofacitinib 10mg BID for 8-weeks of induction, subsequent to tofacitinib 5mg BID for maintenance. It also comprised the proposed alternative to extend the induction period by another eight weeks, for a total of 16-weeks, as well as intended consideration for the application of tofacitinib 10mg BID for maintenance treatment in people with loss of response, an inadequate response, or intolerance to TNF blocker treatment.