The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have accepted for review indication extension filings for AbbVie’s (NYSE: ABBV) interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) for the treatment of moderately to severely active ulcerative colitis (UC). This development marks a further expansion of Skyrizi’s potential applications beyond its previous approvals for plaque psoriasis, psoriatic arthritis, and Crohn’s disease (CD), which were granted by both EMA and FDA.
Collaboration with Boehringer Ingelheim and Supportive Data
The monoclonal antibody (mAb) Skyrizi is the result of a successful collaboration with Boehringer Ingelheim (BI). The submissions for the UC indication extension are supported by robust Phase III clinical trial data. These data demonstrate a higher proportion of patients achieving clinical remission, endoscopic improvement, and histologic endoscopic mucosal improvement with Skyrizi compared to placebo, indicating the drug’s potential efficacy in treating UC.
Potential Impact on Ulcerative Colitis Treatment
The review of Skyrizi’s indication extension by the EMA and FDA is a significant step towards potentially offering a new treatment option for patients suffering from UC. If approved, Skyrizi could become an important tool in the management of this chronic inflammatory bowel disease, further establishing AbbVie’s presence in the autoimmune disease treatment space.-Fineline Info & Tech
