FDA Approves Updated Indication for Upadacitinib (Rinvoq) in IBD

The US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) that updates the indication statement for upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD).1

As described in an October 13, 2025, release from AbbVie, the updated indication statement allows the use of upadacitinib for patients with moderately to severely active UC or CD after they have received ≥ 1 approved systemic therapy in the event tumor necrosis factor (TNF) blockers are clinically inadvisable. Previously, upadacitinib was only indicated for adults who had an inadequate response or intolerance to one or more blockers.1

"At AbbVie, we are committed to addressing the ongoing needs of patients living with inflammatory bowel disease," Kori Wallace, MD, PhD, vice president, global head of immunology clinical development, AbbVie said in a statement.1 "Ulcerative colitis and Crohn's disease can impact every aspect of a patient's life. This label update gives healthcare providers the option to prescribe [upadacitinib] for patients with moderately to severely active inflammatory bowel disease after the use of one approved systemic therapy if TNF blockers are deemed clinically inadvisable by the prescribing physician."

The selective JAK inhibitor boasts a variety of indications across several inflammatory diseases. In 2023, it was granted FDA approval for the treatment of adult patients with moderately to severely active CD who had an inadequate response or intolerance to ≥ 1 anti-TNF medications, building upon previous approvals for UC, rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ankylosing spondylitis, and non-radiographic axial spondylarthritis. Most recently, upadacitinib was granted indications for giant cell arteritis as well as pediatric polyarticular juvenile idiopathic arthritis and psoriatic arthritis.2,3,4

It is also being studied in phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.1

Upadacitinib’s 2023 approval for CD was based on data from the U-EXCEED and U-EXCEL induction studies as well as the U-ENDURE maintenance study. Statistical significance was achieved for the co-primary endpoints and key secondary endpoints with upadacitinib 45 mg in the induction studies and upadacitinib 15 mg and 30 mg in the maintenance study compared to placebo.2

Its 2022 approval for UC was based on data from the U-ACHIEVE and U-ACCOMPLISH induction studies as well as the U-ACHIEVE maintenance studies. Results showed statistically significantly more patients treated with upadacitinib 45 mg achieved clinical remission in the induction studies and more patients treated with upadacitinib 15 mg or 30 mg achieved clinical remission in the maintenance study.5

For both inflammatory bowel disease indications, upadacitinib was initially approved for patients who have had an inadequate response or intolerance to ≥ 1 TNF blockers. With the updated indication statement in both UC and CD, the agent is now able to be used in patients following the receipt of ≥ 1 approved systemic therapy in the event TNF blockers are clinically inadvisable.1

References

1. AbbVie. U.S. Food and Drug Administration (FDA) Approves Updated Indication Statement for RINVOQ® (upadacitinib) for the Treatment of Inflammatory Bowel Disease. October 13, 2025. Accessed October 13, 2025. https://news.abbvie.com/2025-10-13-U-S-Food-and-Drug-Administration-FDA-Approves-Updated-Indication-Statement-for-RINVOQ-R-upadacitinib-for-the-Treatment-of-Inflammatory-Bowel-Disease

2. Walter K. FDA Approves Upadacitinib for Patients With Crohn's Disease. HCPLive. May 18, 2023. Accessed October 13, 2025. https://www.hcplive.com/view/fda-approves-upadacitinib-patients-crohns-disease

3. Johnson V. FDA Approves Upadacitinib, Expanding Treatment for Adults With Giant Cell Arteritis. HCPLive. April 29, 2025. Accessed October 13, 2025. https://www.hcplive.com/view/fda-approves-upadacitinib-expanding-treatment-for-adults-with-giant-cell-arthritis

4. Pine L. Upadacitinib Expands Indication to Pediatric Patients with pJIA, PsA. HCPLive. June 4, 2024. Accessed October 13, 2025. https://www.hcplive.com/view/upadacitinib-expands-indication-to-pediatric-patients-with-pjia-psa

5. Walter K. FDA Approves Upadacitinib for Ulcerative Colitis. HCPLive. March 17, 2022. Accessed October 13, 2025. https://www.hcplive.com/view/fda-approves-upadacitinib-ulcerative-colitis