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U.S. Food and Drug Administration (FDA) Approves Updated Indication Statement for RINVOQ® (upadacitinib) for the Treatment of Inflammatory Bowel Disease
AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) approval of a supplemental new drug application (sNDA) that updates the indication statement 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).
About this update from Abbvie Inc.
[{"type":"text","content":"- Updated indication allows the use of RINVOQ® (upadacitinib) prior to the use of tumor necrosis factor (TNF) blocking agents in patients for whom use of these treatments is clinically inadvisable and who have received at least one approved systemic therapy","length":257,"tagName":"p"},{"type":"text","content":"NORTH CHICAGO, Ill., Oct. 13, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) approval of a supplemental new drug application (sNDA) that updates the indication statement 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).","length":402,"tagName":"p"},{"type":"text","content":"Previously, RINVOQ was indicated for adults with moderately to severely active UC or CD who had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. The updated indication statement also allows the use of RINVOQ for patients after they have received at least one approved systemic therapy in the event TNF blockers are clinically inadvisable.","length":380,"tagName":"p"},{"type":"text","content":""At AbbVie, we are committed to addressing the ongoing needs of patients living with inflammatory bowel disease," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. "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 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."","length":614,"tagName":"p"},{"type":"text","content":"RINVOQ SAFETY CONSIDERATIONS","length":28,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"RINVOQ may cause serious side effects, including:","length":49,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Serious infections. RINVOQ can lower ability to fight infections. Serious infections, some fatal, occurred, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses.","length":189,"tagName":"p"}]},{"val":[{"type":"text...