FDA Approves AbbVie’s Expanded RINVOQ Indication For Adults With Ulcerative Colitis And Crohn’s Disease

AbbVie Inc. has received FDA approval for a supplemental New Drug Application (sNDA) that updates the indication statement for RINVOQ® (upadacitinib), expanding its use in adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). This marks another milestone in AbbVie’s continued efforts to advance treatment options for inflammatory bowel diseases (IBD).

"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."

Previously, RINVOQ was approved only for patients who had shown inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. The updated indication now allows physicians to prescribe RINVOQ to patients who have received at least one systemic therapy, even when TNF blockers are clinically inadvisable, providing greater flexibility in managing these chronic conditions and broadening patient eligibility.

AbbVie emphasized that while RINVOQ offers an important therapeutic advancement, the medication carries serious safety considerations. Potential adverse effects include serious infections (including tuberculosis), increased risk of death, cancers such as lymphoma and lung cancer, and major cardiovascular events like heart attack and stroke, particularly in individuals aged 50 and older with cardiovascular risk factors. Additionally, RINVOQ may cause blood clots, allergic reactions, gastrointestinal tears, and changes in laboratory test results, underscoring the importance of close medical supervision during treatment.