AbbVie has submitted a regulatory application to the Food and Drug Administration (FDA) seeking approval of risankizumab for the treatment of adults with moderately to severely active ulcerative colitis.
The application is supported by data from two phase 3 trials: an induction study, INSPIRE (ClinicalTrials.gov Identifier: NCT03398148) and a maintenance study, COMMAND (ClinicalTrials.gov Identifier: NCT03398135). The INSPIRE trial evaluated 1200mg of intravenous risankizumab administered every 4 weeks as an induction dose, and the COMMAND trial evaluated 180mg and 360mg subcutaneous risankizumab maintenance doses. Both trials included adults with moderately to severely active ulcerative colitis who demonstrated intolerance or inadequate response to conventional therapies and/or advanced therapies (biologics, Janus kinase inhibitors, and S1P receptor modulators).
Findings from INSPIRE and COMMAND showed a significantly greater proportion of patients treated with risankizumab met the primary endpoint achieving clinical remission (per Adapted Mayo Score) compared with placebo. Moreover, risankizumab-treated patients met key secondary endpoints including endoscopic improvement (defined as endoscopic subscore ≤1 without evidence of friability) and histologic endoscopic mucosal improvement (defined as endoscopic subscore ≤1 without evidence of friability and Geboes score ≤3.1).
The safety profile of risankizumab was generally consistent with that observed in previous studies across other indications. There were no new safety risks observed.
“While there has been advancement in therapies to treat ulcerative colitis, there is still an ongoing need for additional treatments to help those seeking relief from its disruptive effects,” said Roopal Thakkar, MD, senior vice president, development, regulatory affairs and chief medical officer, AbbVie. “These submissions demonstrate our continued commitment to helping people living with IBD, and we look forward to providing a potential new treatment option for the management of ulcerative colitis.”
Risankizumab, an interleukin-23 (IL-23) inhibitor, is currently marketed under the trade name Skyrizi and is approved for the treatment of active psoriatic arthritis, moderately to severely active Crohn disease, and moderate to severe plaque psoriasis.
This article originally appeared on MPR
- AbbVie submits regulatory applications to FDA and EMA for risankizumab (Skyrizi®) in ulcerative colitis. News release. AbbVie. Accessed August 28, 2023. https://prnmedia.prnewswire.com/news-releases/abbvie-submits-regulatory-applications-to-fda-and-ema-for-risankizumab-skyrizi-in-ulcerative-colitis-301910373.html.