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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

Jun 15, 2023Skyrizi Met Primary and Key Secondary Endpoints in 52-Week Phase 3 Maintenance Study in Ulcerative Colitis Patients
Jun 17, 2022Approval Skyrizi (risankizumab-rzaa) Receives FDA Approval as the First and Only Specific Interleukin-23 (IL-23) to Treat Moderately to Severely Active Crohn's Disease in Adults
Jan 21, 2022Approval U.S. FDA Approves Second Indication for Skyrizi (risankizumab-rzaa) to Treat Adults with Active Psoriatic Arthritis
Apr 23, 2019Approval FDA Approves Skyrizi (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis
Sep 13, 2018AbbVie Announces Patient-Reported Outcomes Data from Three Pivotal Phase 3 Studies of Risankizumab, Showing Significant Improvements in Health-Related Quality of Life for Patients with Psoriasis
Apr 25, 2018AbbVie Submits Biologics License Application to U.S. FDA for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis
Dec  4, 2017Risankizumab Meets All Primary Endpoints Reporting Positive Results in Fourth Pivotal Phase 3 Psoriasis Study
Oct 26, 2017Risankizumab Meets All Co-Primary and Ranked Secondary Endpoints, Achieving Significantly Greater Efficacy Versus Standard Biologic Therapies in Three Pivotal Phase 3 Psoriasis Studies

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.