Treats moderate-to-severe atopic dermatitis. BLA 761306, held by Eli Lilly And Co. Lebrikizumab-Lbkz.
As of Nov 13, 2026, BLA 761306 (Ebglyss), held by Eli Lilly And Co, was first approved by FDA on Sep 13, 2024, with 3 approved supplements and 1 published complete response letter.
EBGLYSS is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 9, 2026 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Sep 13, 2024 | Original applicationNew molecular entity · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Sep 28, 2023 | LebrikizumabProduct Quality | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ebglyss250MG/2ML · injectable;injection | Lebrikizumab-Lbkz | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 9, 2026 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Oct 28, 2025 | Supplement 5Labeling · Standard review | Approved | |
| May 22, 2025 | Supplement 3Labeling · Standard review | Approved | |
| Sep 13, 2024 | 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
