FDA Expands RINVOQ Use for Ulcerative Colitis and Crohn’s Disease Patients

AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for RINVOQ (upadacitinib), broadening its use in the treatment of moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD).

Previously, RINVOQ was only approved for patients who had inadequate response or intolerance to tumor necrosis factor (TNF) blockers. With this FDA approval, the updated indication now allows use of RINVOQ following at least one approved systemic therapy—even if TNF blockers are considered clinically inadvisable by the prescribing physician.

“This label update gives healthcare providers more flexibility in tailoring treatment options for their patients,” said Dr. Kori Wallace, Vice President, Global Head of Immunology Clinical Development at AbbVie. “It reflects our ongoing commitment to improving care for those living with inflammatory bowel disease.”

RINVOQ, a once-daily oral JAK inhibitor, is part of AbbVie’s expanding immunology portfolio. The medication is already approved for several autoimmune conditions, including rheumatoid arthritis, psoriatic arthritis, and atopic dermatitis.

Important Safety Information

AbbVie highlighted that RINVOQ may pose serious safety risks, including:

• Serious infections, including tuberculosis and viral, bacterial, or fungal infections
• Increased risk of death, cancer, and major cardiovascular events, particularly in patients over 50 with heart disease risk factors
• Blood clots, allergic reactions, and gastrointestinal perforations

The updated label will help physicians consider RINVOQ earlier in treatment sequences, particularly when TNF blockers are unsuitable due to patient-specific risks or contraindications.

AbbVie continues to position RINVOQ as a versatile treatment option within its immunology pipeline, with an emphasis on providing individualized care options for chronic, hard-to-treat diseases.