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Skyrizi (risankizumab)

Region

🇪🇺 EU

Active substance

risankizumab

Company

AbbVie Deutschland GmbH & Co. KG

Status

Authorised

Therapeutic area

Psoriasis; Arthritis, Psoriatic; Colitis, Ulcerative; Crohn Disease

CHMP opinion

Thu 28 Feb 2019

EU approval

Fri 26 Apr 2019

Application

EMEA/H/C/004759

ATC

L04AC18

Official record

www.ema.europa.eu

Indication

Adult plaque 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.

Regulatory milestones

No milestones recorded in the last year.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.