Treats moderate to severe plaque psoriasis. BLA 761338, held by Celltrion, Inc.. Ustekinumab-Stba.
As of Nov 13, 2026, BLA 761338 (Steqeyma), held by Celltrion, Inc., was first approved by FDA on Apr 30, 2025, with 3 approved supplements and 1 published complete response letter.
1. INDICATIONS AND USAGE STEQEYMA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. active psoriatic arthritis (PsA). moderately to severely active Crohn's disease (CD). moderately to severely active ulcerative colitis. Pediatric patients 6 years and older with: moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy. active psoriatic arthritis (PsA). 1.1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 30, 2025 | Original applicationNew active ingredient · Standard review | Approved | |
| Dec 17, 2024 | Original applicationNew active ingredient · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Sep 30, 2024 | CT-P43Product Quality Microbiology, Product Quality | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Steqeyma45MG/0.5ML · injectable;subcutaneous | Ustekinumab-Stba | Rx |
| Steqeyma90MG/ML · injectable;subcutaneous | Ustekinumab-Stba | Rx |
| Steqeyma130MG/26ML · injectable;intravenous | Ustekinumab-Stba | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 12, 2025 | Supplement 7Labeling · Standard review | Approved | |
| Jun 13, 2025 | Supplement 3Labeling · Standard review | Approved | |
| Apr 30, 2025 | Original applicationNew active ingredient · Standard review | Approved | |
| Apr 28, 2025 | Supplement 1Labeling · Standard review | Approved | |
| Dec 17, 2024 | Original applicationNew active ingredient · 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
