Treats moderate-to-severe plaque psoriasis. BLA 761067, held by Sun Pharma Global. Tildrakizumab-Asmn.
As of Nov 13, 2026, BLA 761067 (Ilumya), held by Sun Pharma Global, was first approved by FDA on Mar 20, 2018, with 5 approved supplements and 0 published complete response letters.
ILUMYA is an interleukin-23 antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. active psoriatic arthritis in adult patients. 1.1 Moderate-to-Severe Plaque Psoriasis
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 29, 2026 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Jul 16, 2026 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| Dec 12, 2025 | Supplement 24Efficacy (new indication or use) · Standard review | Approved | |
| Apr 3, 2024 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Dec 19, 2022 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Mar 20, 2018 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ilumya100MG/1ML · injectable;injection | Tildrakizumab-Asmn | Rx |
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
