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2 Information about risankizumab

Marketing authorisation indication

2.1 Risankizumab (Skyrizi, AbbVie) is indicated for 'the treatment of patients 16 years and older with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy, or if such therapies are not advisable'.

2.2 The CE mark for the on-body device that is used to deliver the 360 mg risankizumab solution for injection has not been granted yet. If risankizumab was recommended for moderately to severely active Crohn's disease it would only be available in the UK for this indication after this CE mark is granted.

Dosage in the marketing authorisation

2.3 The dosage schedule is available in the summary of product characteristics for risankizumab.

Price

2.4 The company have stated that the list prices of 600-mg concentrate for solution for infusion (induction treatment) and the on-body device with 360-mg solution for injection (maintenance treatment) are confidential until they are commercially available and cannot be reported here.

2.5 The company has a commercial arrangement. This makes risankizumab available to the NHS with a discount and it would have also applied to this indication if the technology had been recommended.