June 16, 2024

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FDA approves AbbVie’s JAK inhibitor for ulcerative colitis

FDA approves AbbVie’s JAK inhibitor for ulcerative colitis


FDA approves AbbVie’s JAK inhibitor for ulcerative colitis.

On March 17, AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved the expanded indication of the JAK inhibitor Rinvoq (upadacitinib) for the treatment of adult patients with moderately to severely active ulcerative colitis, which has a significant effect on one or more tumors. Insufficient response or intolerance to necrosis factor (TNF) blockade.

The release notes that the approval is Rinvoq’s first indication in the gastroenterology field and is supported by three randomized, double-blind, placebo-controlled clinical studies.




Ulcerative colitis is a chronic, systemic, inflammatory disease caused by inflammation of the large intestine, which causes abdominal pain, bloody diarrhea, severe urgency to defecate, weight loss, and fatigue. Uncertainty about the severity of symptoms and disease recurrence places a heavy burden on patients and often leads to disability.


Discovered and developed by AbbVie scientists, Upadacitinib is an oral once-daily, selective and reversible JAK inhibitor. In August 2019, it received U.S. FDA approval for the treatment of adults with moderately to severely active rheumatoid arthritis who have an inadequate response to or intolerance to methotrexate. The JAK protein family mediates the signaling of various inflammatory factors.

As such, upadacitinib is currently being evaluated in multiple clinical trials for the treatment of a variety of inflammatory diseases, including atopic dermatitis, Crohn’s disease, and psoriatic arthritis. It has been approved for four indications in gastroenterology, dermatology and rheumatology.


In clinical trials, Rinvoq met the primary endpoint of clinical remission at 8 and 52 weeks of treatment.

At the same time, more patients treated with Rinvoq achieved clinical responses and achieved steroid-free clinical remission after 1 year of treatment, as well as key endoscopic and histological improvement endpoints at Weeks 8 and 52.








[1] RINVOQ® (upadacitinib) Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis. Retrieved March 16, 2022

FDA approves AbbVie’s JAK inhibitor for ulcerative colitis

(source:internet, reference only)

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