Skyrizi FDA Approval History
Last updated by Judith Stewart, BPharm on June 19, 2024.
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, Ulcerative Colitis
Skyrizi (risankizumab-rzaa) is an interleukin-23 (IL-23) inhibitor for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
- 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, Crohn's disease, and ulcerative colitis. 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.
- moderately to severely active ulcerative colitis in adults. - Skyrizi is administered by subcutaneous or intravenous injection:
- Plaque Psoriasis and Psoriatic Arthritis - via subcutaneous injection at Week 0, Week 4, then 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.
- Ulcerative Colitis - 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 inflammatory bowel disease).
- Common adverse reactions:
- in plaque psoriasis and psoriatic arthritis patients include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
- in Crohn’s Disease patients during induction dosing include upper respiratory infections, headache, and arthralgia; and during maintenance dosing include arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection.
- in ulcerative colitis patients during induction dosing include arthralgia; and during maintenance dosing include arthralgia, pyrexia, injection site reactions, and rash.
Development timeline for Skyrizi
Further information
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