AbbVie Submits Applications to FDA and EMA for Risankizumab (SKYRIZI®) in Ulcerative Colitis

 

• Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical remission (per Adapted Mayo Score) and key secondary endpoints as an induction and maintenance treatment^1,2
• Safety results were generally consistent with the known safety profile of risankizumab, with no new safety risks observed^1,2 
• Risankizumab is an IL-23 inhibitor being evaluated as a treatment for adults with moderately to severely active ulcerative colitis and is currently approved by FDA and EMA in Crohn's disease, psoriatic arthritis and psoriasis¹

https://www.biospace.com/article/releases/abbvie-submits-regulatory-applications-to-fda-and-ema-for-risankizumab-skyrizi-in-ulcerative-colitis/