Treats generalized pustular psoriasis (GPP). BLA 761244, held by Boehringer Ingelheim Pharmaceuticals Inc. Spesolimab-Sbzo.
As of Nov 13, 2026, BLA 761244 (Spevigo), held by Boehringer Ingelheim Pharmaceuticals Inc, was first approved by FDA on Sep 1, 2022, with 4 approved supplements and 0 published complete response letters.
SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 28, 2025 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Mar 18, 2024 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Sep 1, 2022 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Spevigo900MG · injectable;intravenous | Spesolimab-Sbzo | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 21, 2025 | Supplement 7Labeling · Standard review | Approved | |
| May 28, 2025 | Supplement 6Labeling · Standard review | Approved | |
| May 28, 2025 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Mar 18, 2024 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Sep 1, 2022 | Original applicationNew molecular entity · Priority 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
