Treats severe asthma characterized. BLA 761458, held by Glaxosmithkline LLC. Depemokimab-Ulaa.
As of Nov 13, 2026, BLA 761458 (Exdensur), held by Glaxosmithkline LLC, was first approved by FDA on Dec 16, 2025, with 1 approved supplement and 1 published complete response letter.
EXDENSUR is indicated for the add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. Limitations of Use EXDENSUR is not indicated for the relief of acute bronchospasm or status asthmaticus. EXDENSUR is an interleukin‑5 (IL‑5) antagonist, a monoclonal antibody (humanized immunoglobulin G1 [IgG1] kappa) indicated for add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 16, 2025 | Original applicationNew molecular entity · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Dec 16, 2025 | BLA 761458/Original 2, BLA 761458Clinical/Statistical | Unapproved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Exdensur100MG · injection | Depemokimab-Ulaa | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 10, 2026 | Supplement 2Labeling · Standard review | Approved | |
| Dec 16, 2025 | 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
