AbbVie Submits Regulatory Applications to FDA and EMA for SKYRIZI® (Risankizumab) in Moderately to Severely Active Ulcerative Colitis Based on Positive Phase 3 Trial Results

▎WuXi

Edited by Kant Content Team

AbbVie has submitted a new indication application for Skyrizi (risankizumab) to the U.S. FDA and the European Medicines Agency (EMA) for the treatment of adult patients with moderate to severe ulcerative colitis (UC). This submission is based on data from the Phase 3 INSPIRE and COMMAND clinical trials, which support risankizumab as both induction and maintenance therapy.Analysis shows the trial met the primary endpoint of clinical remission (according to the Adaptive Mayo Score) and key secondary endpoints.

Ulcerative colitis is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) that can cause persistent mucosal inflammation to varying degrees, extending from the rectum to more proximal parts of the colon. The hallmark signs and symptoms of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (sensation of pressure), urgency, and fecal incontinence. The course of ulcerative colitis varies among patients and, in some cases, may lead to complications (including cancer and death) or necessitate surgery. The severity of symptoms and the unpredictable course of the disease impose a heavy burden on patients and can often be disabling.

Risankizumab is a humanized, IgG1 subtype monoclonal antibody that selectively antagonizes IL-23 by binding to the p19 subunit of IL-23.IL-23 is a cytokine associated with inflammation and is considered to be related to many chronic immune diseases. Currently, Skyrizi has received three FDA-approved indications, including Crohn's disease, moderate to severe plaque psoriasis, and active psoriatic arthritis in adults.

The analysis shows,A significantly higher proportion of patients receiving 180mg and 360mg risankizumab achieved clinical remission at week 52: 40% and 38%, respectively, compared to 25% in the control group (p

Among patients receiving 180mg and 360mg risankizumab, 51% and 48% achieved endoscopic improvement, respectively, compared to only 32% in the control group (p

A significantly higher proportion of patients receiving 180 mg and 360 mg risankizumab also achieved corticosteroid-free clinical remission at week 52 (p

The safety results were generally consistent with the safety profile of risankizumab observed in previous studies for other indications, and no new safety risks were identified.

References:

[1] AbbVie Submits Regulatory Applications to FDA and EMAfor Risankizumab (SKYRIZI®) in Ulcerative Colitis. Retrieved August 28, 2023 from https://news.abbvie.com/news/press-releases/abbvie-submits-regulatory-applications-to-fda-and-ema-for-risankizumab-skyrizi-in-ulcerative-colitis.htm?_ga=2.41883746.1356187736.1693256223-984924901.1693256223