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FDA Medication Tracker

← All approvals · Immune & inflammatory · 2025

Exdensur (depemokimab-ulaa)

The FDA approved Exdensur (depemokimab-ulaa) on December 16, 2025 to treat severe asthma characterized by an eosinophilic phenotype as an Komziftiadd-on maintenance therapy.
Brand name
Exdensur
Generic name
depemokimab-ulaa
FDA approval date
December 16, 2025
Approved use (FDA wording)
To treat severe asthma characterized by an eosinophilic phenotype as an Komziftiadd-on maintenance therapy
Company
Glaxosmithkline LLC
Application
BLA761458
Dosage form / route
INJECTION
Boxed warning on label
Not listed
Category on this site
Immune & inflammatory

Indications and usage, from the FDA label

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 [see Warnings and Precautions ( 5.2 )] . 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. ( 1 ) Limitations of Use : Not for relief of acute bronchospasm or status asthmaticus. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.