AbbVie Announces FDA Approval of Updated RINVOQ® (upadacitinib) Indication for Inflammatory Bowel Disease
NORTH CHICAGO, Ill., Oct. 13, 2025 /PRNewswire/ – AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) updating 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).
The newly updated labeling now allows healthcare providers to prescribe RINVOQ for patients in whom tumor necrosis factor (TNF) blockers are clinically inadvisable, provided the patient has received at least one approved systemic therapy. Previously, RINVOQ was indicated only for adults with moderately to severely active UC or CD who had an inadequate response to, or intolerance of, one or more TNF-blocking agents.
“This FDA update represents an important step forward for the inflammatory bowel disease community,” said Kori Wallace, M.D., Ph.D., Vice President and Global Head of Immunology Clinical Development at AbbVie. “Ulcerative colitis and Crohn’s disease are chronic conditions that can profoundly affect every aspect of a patient’s life. By expanding the label for RINVOQ, physicians now have greater flexibility to treat patients with moderate to severe disease after at least one systemic therapy, even when TNF blockers are not suitable.”
Expanded Treatment Options for IBD Patients
Inflammatory bowel disease, including UC and CD, affects millions of adults worldwide and can result in severe gastrointestinal symptoms, including abdominal pain, diarrhea, rectal bleeding, fatigue, and weight loss. Both conditions are associated with systemic inflammation, which can lead to complications beyond the digestive tract, such as arthritis, skin disorders, and eye inflammation.
With the updated FDA approval, RINVOQ can now be considered earlier in the treatment pathway for patients who cannot use TNF blockers due to safety concerns, contraindications, or other clinical considerations. This approval underscores AbbVie’s ongoing commitment to addressing unmet needs in IBD management and providing therapies that improve long-term disease control, patient quality of life, and treatment satisfaction.
RINVOQ Safety Considerations
RINVOQ, a Janus kinase (JAK) inhibitor, has demonstrated efficacy in controlling moderate to severe IBD symptoms, but it carries potential risks that healthcare providers and patients should carefully consider:
- Serious Infections: RINVOQ can lower the body’s ability to fight infections, including tuberculosis (TB), bacterial, fungal, or viral infections. Some infections have been fatal.
- Cardiovascular Risk: Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50 years or older with at least one cardiovascular risk factor.
- Cancer and Immune System Effects: Increased risk of certain cancers, including lymphoma and skin cancers. Current or former smokers are at higher risk for lymphoma and lung cancer.
- Blood Clots: Increased risk of blood clots in veins and arteries, some fatal, particularly in patients 50+ with at least one cardiovascular risk factor.
- Gastrointestinal Risks: Tears in the stomach or intestines.
- Hypersensitivity: Serious allergic reactions, including angioedema and anaphylaxis. Do not use if allergic to RINVOQ or any of its ingredients.
- Laboratory Abnormalities: Potential changes in laboratory test results, which should be monitored by healthcare providers.
Patients and prescribers should carefully weigh the benefits of RINVOQ against potential risks before initiating therapy. For more detailed safety information, visit RINVOQ.com.
Patient Access and Support Programs
AbbVie is committed to helping patients access RINVOQ and other therapies. Eligible commercially insured patients may qualify for co-pay cards, reducing out-of-pocket costs to $0 per month. For patients who are uninsured or face financial barriers, AbbVie offers the myAbbVieAssist program, providing access to medications and financial assistance. Additional information is available at AbbVie Patient Access Support.
About Inflammatory Bowel Disease (IBD)
IBD encompasses chronic conditions such as ulcerative colitis and Crohn’s disease, characterized by immune-mediated inflammation of the gastrointestinal tract. Both diseases are associated with recurrent flares, progressive tissue damage, and complications that can severely affect daily life. Effective management requires therapies that target the underlying inflammation, reduce symptom burden, and prevent long-term complications. The approval of expanded indications for RINVOQ offers patients and clinicians a valuable additional treatment option for moderate to severe IBD.
