Skyrizi FDA Approval History
Last updated by Judith Stewart, BPharm on June 20, 2022.
FDA Approved: Yes (First approved April 23, 2019)
Brand name: Skyrizi
Generic name: risankizumab-rzaa
Dosage form: Injection
Company: AbbVie Inc.
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease
Skyrizi (risankizumab-rzaa) is an interleukin-23 (IL-23) inhibitor for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn's disease.
- Interleukin-23 (IL-23) is a cytokine involved in inflammatory processes that is thought to be linked to a number of chronic immune-mediated diseases, including plaque psoriasis, psoriatic arthritis, and Crohn's disease. Skyrizi works to reduce inflammation by binding to excess IL-23.
- Skyrizi is indicated for:
- moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
- active psoriatic arthritis in adults.
- moderately to severely active Crohn's disease in adults.
- Skyrizi is administered by subcutaneous or intravenous injection:
- Plaque Psoriasis and Psoriatic Arthritis - via subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.
- Crohn’s Disease - induction dosage via intravenous infusion at Week 0, Week 4, and Week 8. Maintenance dosage via subcutaneous injection at Week 12, then every 8 weeks thereafter.
- Skyrizi warnings and precautions include hypersensitivity reactions, increased risk of infection, and hepatotoxicity (in the treatment of Crohn’s Disease).
- Common adverse reactions in plaque psoriasis and psoriatic arthritis patients include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
Common adverse reactions in Crohn’s Disease patients include upper respiratory infections, headache, arthralgia, injection site reactions, abdominal pain, anemia, pyrexia, back pain, arthropathy, and urinary tract infection.
Development timeline for Skyrizi
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