FDA Approves AbbVie's JAK Inhibitor Rinvoq for Moderately to Severely Active Ulcerative Colitis

On March 17, AbbVie announced that the U.S. FDA had approved the JAK inhibitor Rinvoq (upadacitinib) for an expanded indication to treat adult patients with moderate to severe active ulcerative colitis who have had an inadequate response to or were intolerant of one or more tumor necrosis factor (TNF) blockers. The press release noted that this approval marks Rinvoq's first indication in the field of gastroenterology, 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 triggers abdominal pain, bloody diarrhea, severe urgency to defecate, weight loss, and fatigue. The severity of symptoms and the uncertainty of disease recurrence place a heavy burden on patients and often lead to disability.

Upadacitinib, discovered and developed by AbbVie scientists, is a once-daily oral, selective and reversible JAK inhibitor. In August 2019, it received approval from the U.S. FDA for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to or intolerance to methotrexate. The JAK family of proteins mediates signaling of various inflammatory cytokines. As such, upadacitinib is currently being evaluated in multiple clinical trials for the treatment of several inflammatory diseases, including atopic dermatitis, Crohn's disease, and psoriatic arthritis. It has already been approved for four indications in the fields of gastroenterology, dermatology, and rheumatology.

In clinical trials, Rinvoq achieved the primary endpoint of clinical remission at weeks 8 and 52. Meanwhile, more patients treated with Rinvoq achieved clinical response, and after one year of treatment, they attained steroid-free clinical remission as well as met key endoscopic and histologic improvement endpoints at weeks 8 and 52.

References:

[1] RINVOQ® (upadacitinib) Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis. Retrieved March 16, 2022, from https://www.prnewswire.com/news-releases/rinvoq-upadacitinib-receives-fda-approval-for-the-treatment-of-adults-with-moderately-to-severely-active-ulcerative-colitis-301504545.html

(Original text has been abridged)

▽Follow 【WuXi AppTecGermany】WeChat Official Account