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Overview of the safety of EXDENSUR in CRSwNP:

  • EXDENSUR demonstrates a safety profile comparable to placebo.1
  • Adverse events were generally mild to moderate and most resolved within ≤7 days.1,2

Consistent safety profile across 4 Phase III studies involving 773 depemokimab-treated patients.2

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Most AEs resolved within ≤7 days1,2

Adverse events were mild to moderate and temporary.1

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Safety profile comparable to placebo

99% of patients remained on treatment throughout the study period.3,7,8

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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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Patient Profiles

Typical patient cases in which EXDENSUR can make a difference.

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Dosing

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

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Efficacy

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

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  • Abbreviations

    ACQ-5 = Asthma Control Questionnaire-5; CRSwNP = Chronic Rhinosinusitis with Nasal Polyps; CT = Computed Tomography; DMM = Disease-Modifying Medication; INCS = Intranasal Corticosteroids; MMRM = Mixed Model for Repeated Measures; NP = Nasal Polyps; NPS = Nasal Polyp Score; R = Randomization; OP = Surgery; SC = Subcutaneous; SCS = Systemic Corticosteroids; SNOT-22 = Sino-Nasal Outcome Test-22; SoC = Standard of Care; AE = Adverse Event; VRS = Verbal Rating Scale.

  • 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 Bilateral endoscopic Nasal Polyp Score (NPS) ≥5 (≥2 in each nasal cavity), assessed by the investigator.

    d Defined as symptoms of nasal congestion/blockage/obstruction of moderate to severe intensity (VRS score 2–3) together with loss of smell and/or rhinorrhoea (runny nose).

    e All participants remained on Standard of Care (SoC) treatment for CRSwNP throughout the study, regardless of intervention arm. SoC included intranasal corticosteroids (INCS), saline nasal irrigation, occasional short courses of systemic corticosteroids and/or antibiotics, according to local clinical practice.

    f Analysed using a Mixed Model for Repeated Measures (MMRM), including the covariates treatment, baseline value of the relevant endpoint, protocol-defined baseline blood eosinophil count, geographic region, previous sinus surgery, visit, and interaction terms for visit-by-baseline score and visit-by-treatment group. Study was included as an additional covariate in the integrated analysis.

    g The endoscopic NPS was assessed by trained healthcare professionals at the study sites. Endoscopic images were centrally evaluated by two of five blinded independent reviewers according to polyp size (0–8). A third review was performed by an adjudicator if the first two assessments did not agree.

    h Patient self-assessment recorded in an electronic diary using the VRS (0–3 Likert scale).

    i 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

  • References

    1. GlaxoSmithKline EXDENSUR (depemokimab). Summary of Product Characteristics (SmPC).
    2. 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
    3. 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
    4. Gevaert P, et al. Allergy 2024;79:358-904.
    5. ClinicalTrials: NCT05274750 (https://clinicaltrials.gov/study/NCT05274750).
    6. ClinicalTrials: NCT05281523 (https://clinicaltrials.gov/study/NCT05281523).
    7. SWIFT-1 CSR (206713 CSR Report Body 02 SEP 2024)/p19/Table 3.
    8. SWIFT-2 CSR (213744 CSR Report Body 02 SEP 2024)/p19/Table 3.

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