FDA Approves Updated Indication Statement for Upadacitinib in Inflammatory Bowel Disease Treatment

The US FDA has approved a supplemental new drug application that updates the indication statement for upadacitinib (Rinvoq, AbbVie) for treating adults with moderately to severely active ulcerative colitis and Crohn disease, AbbVie announced on October 13, 2025.

The updated indication allows clinicians to prescribe upadacitinib to patients who have received at least one approved systemic therapy when tumor necrosis factor blockers are clinically inadvisable. Previously, upadacitinib was indicated only for adults with moderately to severely active ulcerative colitis or Crohn disease who had an inadequate response or intolerance to one or more TNF blockers.

"This label update gives healthcare providers the option to prescribe RINVOQ 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," Kori Wallace, MD, PhD, vice president and global head of immunology clinical development at AbbVie, said in a press release.

Upadacitinib is a JAK inhibitor discovered and developed by AbbVie. The drug inhibits cytokine-induced STAT phosphorylation mediated by JAK1 and JAK1/JAK3 in human leukocyte cellular assays.

Inflammatory bowel disease encompasses chronic inflammatory conditions of the gastrointestinal tract, with Crohn disease and ulcerative colitis being the most common forms. In both conditions, the immune system causes inflammation and damage to the gut lining. Crohn disease typically manifests as inflammation in the area between the ileum and the colon, causing persistent diarrhea and abdominal pain. Ulcerative colitis is characterized by continuous mucosal inflammation extending from the rectum to the proximal colon, with symptoms including rectal bleeding, abdominal pain, bloody diarrhea, and urgency.

The FDA approval includes warnings about serious side effects associated with upadacitinib, including serious infections, increased risk of death in patients aged 50 years and older with at least one heart disease risk factor, cancers, major cardiovascular events, blood clots, allergic reactions, and gastrointestinal tears.

AbbVie offers patient support programs, including a copay card that may reduce out-of-pocket costs to $0 per month for eligible commercially insured patients. Uninsured patients may be eligible for the company's patient assistance program.

Source: U.S. Food and Drug Administration (FDA) Approves Updated Indication Statement for RINVOQ® (upadacitinib) for the Treatment of Inflammatory Bowel Disease. AbbVie. News release. 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