What Was Approved?
On December 16, 2025, the U.S. Food and Drug Administration approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in adults and pediatric patients 12 years of age and older.
Exdensur is not intended to replace a rescue inhaler for sudden asthma symptoms.
How Is Exdensur Given?
Exdensur is administered by subcutaneous injection once every six months.
It is used in addition to a patient’s existing asthma treatment rather than as a stand-alone therapy.
What Did the Clinical Trials Show?
FDA approval was supported by the SWIFT-1 and SWIFT-2 trials involving 762 patients whose asthma remained inadequately controlled despite background therapy.
Over 52 weeks, Exdensur reduced the annualized rate of clinically significant asthma exacerbations compared with placebo.
The reduction was:
- 58% in SWIFT-1
- 48% in SWIFT-2
These results describe the study populations and do not guarantee the same outcome for every patient.
What Are Common Side Effects?
The most common adverse reactions reported more often with Exdensur than placebo included:
- Upper respiratory tract infection
- Allergic rhinitis
- Influenza
- Joint pain
- Pharyngitis
Other adverse effects may also occur.
Who Is Exdensur For?
Exdensur is specifically approved for severe asthma with an eosinophilic phenotype.
It should not be described as a general treatment for every type of asthma.
Patients should continue their prescribed controller medications unless their healthcare professional recommends a change.
Bottom Line
Exdensur (depemokimab-ulaa) is a newly FDA-approved biologic for patients age 12 and older with severe eosinophilic asthma.
Its once-every-six-months dosing provides a new maintenance-treatment option, but it is an add-on therapy and is not intended for rapid relief of acute asthma symptoms.
Sources
- U.S. Food and Drug Administration (FDA) — Drug Trials Snapshot: Exdensur.
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2025.