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Skyrizi Approval History

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

Skyrizi (risankizumab-rzaa) is an interleukin-23 (IL-23) inhibitor for the treatment of plaque psoriasis.

Development History and FDA Approval Process for Skyrizi

DateArticle
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
Nov 30, 2016AbbVie Receives Orphan Drug Designation for Investigational IL-23 Inhibitor Risankizumab from the FDA for the Treatment of Pediatric Patients with Crohn's Disease
May 24, 2016IL-23 Inhibitor Risankizumab Induces Remission in Phase II Study in Patients with Moderate-to-Severe Crohn's Disease

Further information

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