On 22 August 2024, AbbVie announced that the UK’s National Institute for Health and Care Excellence (NICE) issued final Technology Appraisal Guidance recommending Skyrizi® (risankizumab) as a treatment option for adults with moderately to severely active ulcerative colitis (UC) who cannot tolerate or have not responded to conventional, biological or TNF-alpha inhibitor treatments, or when TNF-alpha inhibitors are unsuitable. AbbVie reports that this recommendation closely follows the UK Medicines and Healthcare Products Regulatory Agency’s approval on 21 August 2024.
Earlier this year, in July 2024, the European Commission approved Skyrizi® for UC. The UC indication was also approved in the US in June 2024, following AbbVie’s FDA application in August 2023.
Skyrizi® received Korean approval in November 2023 for moderately to severely active Crohn’s disease.