SKYRIZI® (Risankizumab) Receives Positive Opinion for Ulcerative Colitis Treatment in Europe


AbbVie has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of risankizumab (SKYRIZI®) for the treatment of adults with moderately to severely active ulcerative colitis (UC). The recommendation applies to patients who have had an inadequate response, lost response, or were intolerant to either conventional or biologic therapy.

Risankizumab is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including UC. If approved, risankizumab will provide a new treatment option for patients with moderately to severely active UC in Europe.