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Overview of the safety of EXDENSUR in severe asthma with Type 2 inflammation:

  • EXDENSUR demonstrates a safety profile comparable to placebo.1
  • 99% of patients remained on treatment throughout the study period.2,3
  • Adverse events were generally mild to moderate and most resolved within ≤ 7 days.1

EXDENSUR demonstrates a safety profile comparable to placebo in severe asthma.1

A total of 773 depemokimab-treated patients across four Phase III studies were included in the analysis.4

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Adverse events were generally mild to moderate1

Most administration-related events resolved within ≤ 7 days.1

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Most common adverse reactions (≥1/100 to <1/10):1

  • Pruritus
  • Administration-related systemic reactions (non-allergic)a
  • Local injection-site reactionsb

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In only 1% of patients, AEs led to permanent discontinuation of study treatment or study withdrawal.2,3

These results suggest good treatment acceptability.

More about Exdensur

Teaser Patientenprofile

Patient Profiles

Typical patient cases in which EXDENSUR can make a difference.

View Patient Profiles
Teaser Dosierung

Dosing

Only 2 injections per year for ultra-long-lasting efficacy.1

More about Dosing
Teaser Sicherheit

Efficacy

With only 2 injections per year, EXDENSUR is the first and only biologic to deliver ultra-long-acting protection in severe, uncontrolled asthma with type 2 inflammationf and/or severe, uncontrolled CRSwNP.1,5,10-16

Learn more

  • Abbreviations

    ACQ-5 = Asthma Control Questionnaire-5; EOS = Blood Eosinophil Count; FEV₁ = Forced Expiratory Volume in 1 Second; FP = Fluticasone Propionate; HFA = Hydrofluoroalkane; HR = Hazard Ratio; ICS = Inhaled Corticosteroid(s); IL = Interleukin; i.m. = Intramuscular; i.v. = Intravenous; CI = Confidence Interval; LS = Least Squares; LABA = Long-Acting Beta₂ Agonist; LAMA = Long-Acting Muscarinic Antagonist; OCS = Oral Corticosteroids; SE = Standard Error; SGRQ = St George's Respiratory Questionnaire; SoC = Standard of Care; AE = Adverse Event; CRSwNP = Chronic Rhinosinusitis with Nasal Polyps.

  • Footnotes

    a Symptoms include headache, fatigue and rash.

    b Symptoms include pain, redness, swelling and pruritus. Most events were mild. 67% of events resolved within ≤7 days and 50% resolved within ≤2 days.1

    c ≥5 patients in both treatment arms across both studies.

    d Stable asthma maintenance therapy consisted of medium- to high-dose ICS (≥440 μg FP HFA daily or a clinically comparable regimen) plus at least one additional controller such as LABA or LAMA, with or without OCS (standard asthma care excluding biologics).

    e Worsening of asthma requiring systemic corticosteroids (SCS), hospitalization or an emergency department visit. SCS use was defined as a single intramuscular dose or oral/intravenous administration for ≥3 days. For participants receiving maintenance SCS therapy, at least a doubling of the existing dose for ≥3 days was required.

    f The SWIFT-1/2 studies included patients with severe asthma receiving either medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication. The full SWIFT-1/2 data set is included in the EXDENSUR SmPC. Results presented here are, as per SmPC, based on the overall study population. In Belgium, EXDENSUR is indicated as add-on maintenance treatment for severe asthma with type 2 inflammation in patients aged ≥12 years who are inadequately controlled despite high-dose ICS plus another asthma controller.1,4

    EXDENSUR is indicated as add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.1

  • References

    1. GlaxoSmithKline EXDENSUR (depemokimab). Summary of Product Characteristics (SmPC).
    2. SWIFT-1 CSR (206713 CSR Report Body 02 SEP 2024)/p19/Table 3.
    3. SWIFT-2 CSR (213744 CSR Report Body 02 SEP 2024)/p19/Table 3.
    4. Jackson DJ, Bourdin A, Blackorby A, et al. Safety and Tolerability of Twice-Yearly Depemokimab in Patients with Asthma and Chronic Rhinosinusitis with Nasal Polyps: Pooled Results from SWIFT-1/-2 and ANCHOR-1/-2. Adv Ther. 2025 Dec 29. doi: 10.1007/s12325-025-03457-4. Reference link
    5. Jackson DJ, Wechsler ME, Jackson DJ, et al. Twice-yearly depemokimab in severe asthma with an eosinophilic phenotype (Suppl. Appendix). N Engl J Med. 2024;391(24):2337-2349. Reference link
    6. ClinicalTrials.gov, NCT04719832.
    7. ClinicalTrials.gov, NCT04718103.
    8. ClinicalTrials.gov, NCT05243680.
    9. Gevaert P, Desrosiers M, Cornet M, et al. Efficacy and safety of twice per year depemokimab in chronic rhinosinusitis with nasal polyps (ANCHOR-1 and ANCHOR-2): phase 3, randomized, double-blind, parallel trials. Lancet. 2025;405(10482):911-926. Reference link
    10. GlaxoSmithKline. Nucala (mepolizumab). Summary of Product Characteristics (SmPC).
    11. AstraZeneca. Fasenra (benralizumab). Summary of Product Characteristics (SmPC).
    12. AstraZeneca. Tezspire (tezepelumab-ekko). Summary of Product Characteristics (SmPC).
    13. Sanofi. Dupixent (dupilumab). Summary of Product Characteristics (SmPC).
    14. Novartis Europharm Limited. Xolair (omalizumab). Summary of Product Characteristics (SmPC).
    15. Teva Pharmaceuticals Cinqaero (reslizumab). Summary of Product Characteristics (SmPC).
    16. Global Initiative for Asthma(GINA) 2026. Global Strategy for Asthma Management and Prevention. Available at: https://ginasthma.org/2026-gina-strategy-report/ Accessed June 15, 2026.

PM-BE-DEPE-WCNT-260011 - September 2026