AbbVie's IL-23 Inhibitor Skyrizi Gains EU Approval for Moderate to Severe Ulcerative Colitis

On July 27, AbbVie (AbbVie, ABBV.US) announced that the European Commission has approved Skyrizi (risankizumab) for the treatment of adult patients with moderate to severe active ulcerative colitis (UC) who have had an inadequate response, lost response, or are intolerant to conventional therapies or biologics. This is the fourth indication for Skyrizi approved in the European Union.

Skyrizi 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 linked to many chronic immune diseases. Previously, Skyrizi has been approved by the EU for three indications, including Crohn's disease, moderate to severe plaque psoriasis, and active psoriatic arthritis in adults.