Skyrizi - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

risankizumab

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.

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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

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
• Estado:
  Positive