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.

EXDENSUR is not indicated for the relief of acute bronchospasm or status asthmaticus

Injection: 100 mg/mL of depemokimab‑ulaa as a colorless, yellow to brown, clear to opalescent solution in a single‑dose, prefilled syringe with needle guard.

None.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

If an overdosage occurs, the patient should be treated supportively with appropriate monitoring as necessary. Consider contacting the Poison Help line (1‑800‑222‑1222) or a medical toxicologist for additional overdose management recommendations.

Depemokimab‑ulaa is an interleukin‑5 (IL‑5) antagonist monoclonal antibody (humanized immunoglobulin G1 [IgG1] kappa). Depemokimab‑ulaa is produced by recombinant DNA technology in Chinese hamster ovary cells. The estimated molecular weight of depemokimab‑ulaa is 149 kDa.

EXDENSUR (depemokimab‑ulaa) injection is a sterile, preservative‑free, colorless, yellow to brown, clear to opalescent solution for subcutaneous use.

EXDENSUR injection is supplied in a single‑dose, 1‑mL, prefilled syringe with a fixed 29‑gauge, half‑inch needle with a needle guard. Each 1 mL delivers 100 mg depemokimab‑ulaa, (8.43 mg) arginine HCl, (0.017 mg) edetate disodium, (1.41 mg) histidine, (2.29 mg) L‑histidine HCl monohydrate, (0.20 mg) polysorbate 80, (61.6 mg) trehalose, and Water for Injection with a pH of 6.0.

The efficacy of EXDENSUR for the add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype was evaluated in 2 replicate, randomized (2:1 to EXDENSUR or placebo), double‑blind, parallel‑group, placebo‑controlled, multicenter clinical trials (SWIFT‑1 [NCT04719832] and SWIFT‑2 [NCT04718103]) of 52 weeks duration. The trials enrolled adult and pediatric patients aged 12 years and older with asthma characterized by an eosinophilic phenotype, defined as a blood eosinophil count ≥150 cells/mcL at screening or ≥300 cells/mcL documented in the year prior to study entry. Patients were required to have 2 or more asthma exacerbations requiring treatment with systemic corticosteroids (SCS) in the prior year while on background asthma therapy consisting of a medium‑ to high‑dose inhaled corticosteroids (ICS) plus at least one additional asthma controller with or without maintenance oral corticosteroids (OCS). Patients were also required to have reduced lung function at baseline (pre‑bronchodilator forced expiratory volume in 1 second [FEV

The demographics and baseline characteristics of the efficacy population in SWIFT‑1 and SWIFT‑2 are provided in

The primary efficacy endpoint for SWIFT‑1 and SWIFT‑2 was the annualized rate of clinically significant exacerbations over the 52‑week treatment period. A clinically significant exacerbation was defined as worsening of asthma requiring use of SCS such as intravenous or oral steroids for at least 3 days or a single intramuscular corticosteroid dose and/or hospitalization and/or Emergency Department visit. For patients on maintenance SCS, at least double the existing maintenance dose for at least 3 days was required. All patients experiencing an exacerbation were treated with SCS.

In SWIFT‑1 and SWIFT‑2, the annualized rate of asthma exacerbations was significantly lower in patients receiving EXDENSUR compared to placebo (

The percentage of patients with exacerbations requiring hospitalization and/or Emergency Department visit was numerically lower for patients treated with EXDENSUR (1% and 4%) compared with placebo (8% and 10%) in SWIFT‑1 and SWIFT‑2, respectively.

In SWIFT‑1 and SWIFT‑2, the time to first clinically significant exacerbation was longer for EXDENSUR compared to placebo (Figures

In SWIFT‑1 and SWIFT‑2, the mean change from baseline in pre‑bronchodilator FEV

In SWIFT‑1 and SWIFT‑2, the proportion of ACQ‑5 responders (clinically meaningful improvement defined as a decrease in score of 0.5 or more) at Week 52 was 54% for EXDENSUR in both studies compared to 55% and 53%, respectively, for placebo.

EXDENSUR (depemokimab‑ulaa) injection is a sterile, preservative‑free, colorless, yellow to brown, clear to opalescent solution for subcutaneous use. The syringe is not made with natural rubber latex. EXDENSUR injection is supplied as described in

Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.

Do not freeze. Do not shake. Avoid exposure to heat.

The prefilled syringe can be removed from the refrigerator and kept in the unopened carton, protected from light for up to 7 days at room temperature up to 86°F (30°C). Discard if left out of the refrigerator for more than 7 days.

The prefilled syringe must be administered within 8 hours once removed from the carton. Discard if not administered within 8 hours.

Advise the patient to read the FDA‑approved patient labeling (Patient Information).

Inform patients of hypersensitivity reactions, including anaphylaxis, that can occur following administration of EXDENSUR. Instruct patients to contact their healthcare provider if they experience symptoms of a hypersensitivity reaction

Inform patients that EXDENSUR does not treat acute asthma symptoms or acute exacerbations. Advise patients to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with EXDENSUR

Advise patients to not abruptly discontinue systemic or inhaled corticosteroids after initiation of EXDENSUR therapy. Inform patients that reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. Inform patients that reductions in corticosteroid dose, if appropriate, should be gradual and performed under the supervision of a healthcare provider

Advise patients that the potential clinical impact of prolonged and increased EXDENSUR exposure in infants that were exposed

Advise patients who are exposed to EXDENSUR during pregnancy to contact GlaxoSmithKline at 1‑888‑825‑5249.

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