The positive opinion is based on results from two pivotal Phase 3 trials, INSPIRE and COMMAND, that evaluated the efficacy and safety of risankizumab in adults with moderately to severely active ulcerative colitis (UC)1,2In both trials, the primary endpoint of clinical remission (per Adapted Mayo Score*) and key secondary endpoints, including endoscopic improvement** and histologic-endoscopic mucosal improvement,† were met1,2UC is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) affec ...