The U.S. Food and Drug Administration (FDA) has approved an updated indication for AbbVie's RINVOQ (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease. This approval, announced on October 13, 2025, expands the drug's label to be used in patients who have received at least one approved systemic therapy, particularly when tumor necrosis factor (TNF) blockers are considered clinically inadvisable. Previously, RINVOQ was indicated for patients who had an inadequate response or intolerance to TNF blockers. This label update provides physicians with greater flexibility in prescribing treatments for inflammatory bowel disease (IBD). The expanded approval is expected to contribute to AbbVie's revenue, which stands at an impressive $58.3 billion annually. In response to the news, AbbVie's shares (ABBV) experienced a 1% increase at the time of the announcement on October 13th.
AbbVie's RINVOQ Receives FDA Approval for Expanded Use in IBD Treatment
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