FDA

FDA expands Rinvoq indication for IBD

October 21, 2025

On October 13, 2025, FDA approved a supplemental new drug application that updates the indication for Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD).

Previously, Rinvoq was indicated for adults with moderately to severely active UC or CD who had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. The updated indication allows for the use of Rinvoq for patients after they've received at least one approved systemic therapy in the event TNF blockers are clinically inadvisable.

Sources:

Rinvoq (upadacitinib) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211675Orig1s028,218347Orig1s005lbl.pdf Revised October 2025. Accessed October 20, 2025.