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

Core Viewpoint - AbbVie announced the FDA approval of a supplemental new drug application (sNDA) for RINVOQ (upadacitinib), allowing its use in adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD) after one approved systemic therapy when TNF blockers are clinically inadvisable [1][2]. Group 1: Product Information - RINVOQ is now indicated for patients with moderately to severely active UC or CD who have had an inadequate response or intolerance to one or more TNF blockers, and can be prescribed after one approved systemic therapy if TNF blockers are not suitable [2]. - RINVOQ is a JAK inhibitor developed by AbbVie, which is being studied for various immune-mediated inflammatory diseases [9][10]. Group 2: Patient Support and Access - AbbVie offers a patient support program and a co-pay card that may reduce out-of-pocket costs to $0 per month for eligible, commercially insured patients [5]. - The company has a Patient Assistance Program, myAbbVieAssist, for uninsured patients or those unable to afford their medication [5]. Group 3: Company Commitment - AbbVie is dedicated to addressing the needs of patients with inflammatory bowel disease (IBD), aiming to alleviate the physical, emotional, and economic burdens associated with UC and CD [2][8]. - The company is committed to innovative research in gastroenterology, focusing on developing treatments for IBD [32].