India Pharma Outlook Team | Wednesday, 15 October 2025
AbbVie received an approval from the U.S. Food and Drug Administration (FDA) to a supplemental new drug application (sNDA) for RINVOQ (upadacitinib). The approval includes a revised indication for the drug in adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD).
Before the change, RINVOQ was only recommended for patients who had an insufficient response or were intolerant to tumor necrosis factor (TNF) blockers.
"The two major types of inflammatory bowel disease findings, UC and CD, substantially affect patients’ quality of life," said Kori Wallace, M.D., Ph.D., Vice President and Global Head of Immunology Clinical Development at AbbVie. "With this change, clinicians get a broader range of options at their disposal in managing patients with moderately to severely active IBD."
RINVOQ, a selective JAK inhibitor, was invented and developed by AbbVie scientists and is now under investigation for various immune-mediated inflammatory diseases. In one-cell assays, RINVOQ showed very effective blocking of cytokine-induced STAT phosphorylation through JAK1 and JAK1/JAK3 pathways.
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The drug’s effectiveness and safety are still to be proven in clinical trials, which are presently at phase 3, for diseases such as alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.
Inflammatory bowel disease is the overarching term for the body’s chronic and progressive inflammatory response in the lower digestive tract, with UC being a disease of large intestine whereas CD mostly affecting the ileum and colon.
Symptoms which are common to both of these diseases, include abdominal pain, diarrhea, and rectal bleeding. These symptoms are a major physical, emotional, and economic burden on the patients.
