Summary of opinion: Skyrizi, 23/04/2026 Positive
Summary of opinion: Skyrizi, 23/04/2026 Positive
Opinion
On 23 April 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Skyrizi. The marketing authorisation holder for this medicinal product is AbbVie Deutschland GmbH & Co. KG.
The CHMP adopted a new indication as follows:
Adult Pplaque psoriasis
Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Paediatric plaque psoriasis
Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.
Psoriatic arthritis
Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
Crohn’s disease
Skyrizi is indicated for the treatment of adult patients 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.
Ulcerative colitis
Skyrizi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
Note: New text in bold, removed text as strikethrough
CHMP post-authorisation summary of positive opinion for Skyrizi (X-0000296763)
Adopted
Reference Number:
EMADOC-1700519818-3075007
English (EN) (122.47 KB - PDF)
First published:
24/04/2026
View
Key facts
Name of medicine
Skyrizi
EMA product number
EMEA/H/C/004759
Active substance
risankizumab
International non-proprietary name (INN) or common name
risankizumab
Therapeutic area (MeSH)
- Psoriasis
- Arthritis, Psoriatic
- Colitis, Ulcerative
- Crohn Disease
Anatomical therapeutical chemical (ATC) code
L04AC18
Marketing authorisation holder
AbbVie Deutschland GmbH & Co. KG
Date of opinion
23/04/2026
Status
Positive
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More information on Skyrizi
This page was last updated on
24/04/2026
Summary
On 23 April 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Skyrizi. The marketing authorisation holder for this medicinal product is AbbVie Deutschland GmbH & Co. KG. The CHMP adopted a new indication as follows: Adult Pplaque psoriasis Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Paediatric plaque psoriasis Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy. Psoriatic arthritis Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Crohn's disease Skyrizi is indicated for the treatment of adult patients 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. Ulcerative colitis Skyrizi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy. Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission. Note: New text in bold, removed text as strikethrough