EFFICACY IN SEVERE ASTHMA*

Protection from exacerbations

*Characterized by an eosinophilic phenotype.

Protection from exacerbations

Primary endpoint: Reduction in annualized rate of exacerbations,* EXDENSUR + SOC vs placebo + SOC.1

Exacerbation data over 52 weeks

SWIFT-1: EXDENSUR, 0.46/year (n=250) vs placebo, 1.11/year (n=132). RR: 0.42 (58% reduction, P<0.001)
SWIFT-2: EXDENSUR, 0.56/year (n=252) vs placebo, 1.08/year (n=128). RR: 0.52 (48% reduction, P<0.001)

Mean rate of exacerbations in previous year: SWIFT-1, 2.2; SWIFT-2, 2.7.

*Defined as worsening of asthma requiring: systemic corticosteroids (IV or oral for ≥3 days or single IM dose) or hospitalization or ED visit; or at least doubling the existing maintenance systemic corticosteroid dose for ≥3 days.

SWIFT STUDY DESIGN

Post hoc subgroup analyses: Exacerbation data across patient subgroups

    ACQ-5=Asthma Control Questionnaire (5-item); CI=confidence interval; ED=emergency department; ICS=inhaled corticosteroids; IM=intramuscular; IV=intravenous; RR=rate ratio; SOC=standard of care.

    More patients with zero exacerbations2

    Exacerbations at week 52 vs placebo

    SWIFT-1/2 pooled analysis. Results are descriptive.

    SWIFT STUDY DESIGN

    Time to first exacerbation

      Exacerbation-related hospital visits*

      Hospitalization or ED visit data over 52 weeks

      EXDENSUR, 0.02/year (n=502) vs placebo, 0.09/year (n=260). RR: 0.28 (95% CI: 0.13, 0.61).

      SWIFT-1/2 pooled analysis. Results are descriptive.

      More patients on EXDENSUR had ZERO EXACERBATIONS requiring hospitalization/ED visit over 52 weeks1

      99% OF PATIENTS on EXDENSUR (n=250) vs 92% on placebo (n=132) in SWIFT-1

      96% OF PATIENTS on EXDENSUR (n=252) vs 90% on placebo (n=128) in SWIFT-2

      All results are descriptive.

      SWIFT STUDY DESIGN
      • *

        Hospitalizations or ED visits.

      • †

        The annualized rate of exacerbations leading to hospitalization or ED visit was not calculated in SWIFT-1 because fewer than 20 such exacerbations occurred. However, the pooled analysis included the number of events from both trials to calculate the annualized rate.

      CI=confidence interval; ED=emergency department; RR=rate ratio.

      More to explore:

      Safety

      Learn more about the established safety profile of EXDENSUR from two phase 3 clinical trials.

      SEE SAFETY PROFILE

      Confidence with in-office administration

      In-office administration allows you to confidently deliver 6 months of therapy with every subcutaneous (SC) injection.

      LEARN ABOUT DOSING

      Indication & Safety Info

      Indication

      Important Safety Information

      Indication

      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.

      Important Safety Information

      WARNINGS AND PRECAUTIONS

      Hypersensitivity Reactions
      Hypersensitivity reactions, including anaphylaxis, can occur following administration of EXDENSUR. If a hypersensitivity reaction occurs, discontinue EXDENSUR and initiate appropriate therapy.

      Acute Asthma Symptoms or Deteriorating Disease
      EXDENSUR should not be used to treat acute asthma symptoms or acute exacerbations.

      Risk Associated with Abrupt Reduction of Corticosteroid Dosage
      Upon initiation of EXDENSUR therapy, do not abruptly discontinue systemic or inhaled corticosteroids. Reductions in corticosteroid dose, if appropriate, should be gradual and under the supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

      Parasitic (Helminth) Infection
      Patients with pre-existing helminth infections should be treated for their infection prior to initiation of EXDENSUR therapy. If patients become infected while receiving EXDENSUR and do not respond to anti-helminth treatment, discontinue EXDENSUR until the infection resolves.

      ADVERSE REACTIONS

      In patients receiving EXDENSUR, the most common adverse reactions (≥4%) were upper respiratory tract infection, allergic rhinitis, influenza, arthralgia, and pharyngitis. Injection site reactions have also occurred. 

      USE IN SPECIFIC POPULATIONS

      The data in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Transport of endogenous IgG antibodies and monoclonal antibodies, such as depemokimab-ulaa, across the placenta increases as pregnancy progresses and peaks during the third trimester.

      EXDENSUR can cross the placenta during pregnancy and the presence of the YTE modification may prolong and increase exposure to the infant exposed in utero. The impact of transmission to the fetus should be considered. Pregnant women exposed to EXDENSUR, or their healthcare providers, should report EXDENSUR exposure by calling 1-888-825-5249.

      Please see full Prescribing Information for EXDENSUR.

      To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249 or
      FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

      References

      1. Jackson DJ, Wechsler ME, Jackson DJ, et al. Twice-yearly depemokimab in severe asthma with an eosinophilic phenotype. N Engl J Med. 2024;391(24):2337-2349. doi:10.1056/NEJMoa2406673

      2. Data on file. GSK.

      3. Juniper EF, Svensson K, Mörk AC, Ståhl E. Measurement properties and interpretation of three shortened versions of the asthma control questionnaire. Respir Med. 2005;99(5):553-558.

      4. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention, 2025. Updated November 2025. Available at: https://ginasthma.org/2025-gina-strategy-report/. Accessed December 17, 2025.