FDA Ulcerative Colitis Guidance: 'Ideal' Vision Vs. Practical Interim Approach
Agency favors assessments of signs/symptoms and endoscopy findings using well-defined and reliable patient- and clinician-reported outcomes instruments; since these don't exist, FDA will allow tweaking of existing assessment tools in the interim.
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Pfizer Inc. released positive Phase III data from two induction trials testing its oral Janus kinase inhibitor Xeljanz (tofacitinib) in patients with the inflammatory bowel disease ulcerative colitis, but the company will await the results of another Phase III maintenance study before filing for an indication expansion.
Changes in how efficacy of ulcerative colitis drugs are measured are coming, but FDA GREAT2 workshop focused on criteria to use in the interim. An academic/industry consortium plans to submit proposed patient-reported outcome questionnaires for UC and Crohn’s disease to the agency Dec. 20.
Panelists at an agency workshop discussed tweaks to the Mayo Clinic Score while patient-reported outcome instruments are being developed in an initiative to create an improved ulcerative colitis endpoint.