Treats moderate-to-severe plaque psoriasis. BLA 761105, held by Abbvie Inc. Risankizumab-Rzaa.
As of Nov 13, 2026, BLA 761105 (Skyrizi), held by Abbvie Inc, was first approved by FDA on Apr 23, 2019, with 16 approved supplements and 0 published complete response letters.
SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. active psoriatic arthritis in adults and pediatric patients 6 years of age and older. moderately to severely active Crohn's disease in adults. moderately to severely active ulcerative colitis in adults. 1.1 Plaque Psoriasis SKYRIZI is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 23, 2026 | Supplement 53Efficacy (new indication or use) · Priority review | Approved | |
| Jun 26, 2026 | Supplement 45Efficacy (new indication or use) · Standard review | Approved | |
| Jun 12, 2026 | Supplement 44Efficacy (new indication or use) · Standard review | Approved | |
| Mar 6, 2026 | Supplement 42Efficacy (new indication or use) · Standard review | Approved | |
| Sep 3, 2025 | Supplement 39Efficacy (new indication or use) · Standard review | Approved | |
| Jun 18, 2024 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Sep 23, 2022 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Jun 16, 2022 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Jan 21, 2022 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Apr 26, 2021 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Apr 26, 2021 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Apr 23, 2019 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Skyrizi75MG/0.83ML · injectable;injection | Risankizumab-Rzaa | Rx |
| Skyrizi150MG/ML · injectable;injection | Risankizumab-Rzaa | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 23, 2026 | Supplement 53Efficacy (new indication or use) · Priority review | Approved | |
| Jun 26, 2026 | Supplement 45Efficacy (new indication or use) · Standard review | Approved | |
| Jun 12, 2026 | Supplement 44Efficacy (new indication or use) · Standard review | Approved | |
| Mar 18, 2026 | Supplement 47Labeling · Standard review | Approved | |
| Mar 6, 2026 | Supplement 42Efficacy (new indication or use) · Standard review | Approved | |
| Sep 3, 2025 | Supplement 39Efficacy (new indication or use) · Standard review | Approved | |
| May 7, 2025 | Supplement 38Labeling · Standard review | Approved | |
| Jun 18, 2024 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Mar 4, 2024 | Supplement 27Labeling · Standard review | Approved | |
| Jan 3, 2024 | Supplement 32Labeling · Standard review | Approved | |
| Sep 23, 2022 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Jun 16, 2022 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Jan 21, 2022 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Apr 26, 2021 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Apr 26, 2021 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Mar 20, 2020 | Supplement 5Labeling · Standard review | Approved | |
| Apr 23, 2019 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
