Basic Information
Skyrizi
Regulatory Information
EMEA/H/C/004759
April 26, 2019
February 28, 2019
26
August 27, 2024
Company Information
Germany
Knollstrasse 67061 Ludwigshafen
AbbVie Deutschland GmbH & Co. KG
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Plaque Psoriasis Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults 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.
Overview Summary
Skyrizi is a medicine used to treat adults with: - moderate-to-severe plaque psoriasis (a disease causing red, scaly patches on the skin) who require systemic treatment (treatment with medicines given by mouth or by injection); - active psoriatic arthritis (a disease that causes psoriasis and inflammation of the joints) when treatment with one or more medicines known as disease-modifying anti-rheumatic drugs (DMARDs) has not worked well enough or causes unacceptable side effects; - moderate-to-severe Crohn’s disease (a disease causing inflammation of the digestive tract) when conventional or biological treatments do not work well enough or cause unacceptable side effects; - ulcerative colitis (inflammation of the large intestine causing ulceration and bleeding) when conventional or biological treatments do not work well enough or cause unacceptable side effects. When used for psoriatic arthritis, Skyrizi can be given alone or with another medicine, methotrexate. Skyrizi contains the active substance risankizumab.