AbbVie Positive CHMP Opinion for SKYRIZI® in Ulcerative Colitis

 

• 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)^1,2
• In 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 met^1,2
• UC is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) affecting the large intestine. It can lead to a substantial burden and often results in disability

https://www.biospace.com/article/releases/abbvie-receives-positive-chmp-opinion-for-risankizumab-skyrizi-for-the-treatment-of-adults-with-moderately-to-severely-active-ulcerative-colitis/