GSK secures EU approval for Exdensur in severe asthma and CRSwNP

GSK plc (LON:GSK, NYSE: GSK) has announced the European Commission has approved Exdensur (depemokimab) in two indications:

·      as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite high dose inhaled corticosteroids (ICS) plus another asthma controller;

·      as an 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.

The approval is based on data from the SWIFT and ANCHOR phase III trials, which showed sustained efficacy with a twice-yearly dosing regimen for depemokimab. Each of the four trials met their primary or co-primary endpoints with statistically significant and clinically meaningful results, comparing the addition of depemokimab to standard of care versus standard of care alone.^1,2

Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, GSK, said: “The approval of Exdensur in the EU means there is now an innovative ultra-long-acting option that offers sustained efficacy over 6 months to protect patients from severe asthma exacerbations and the debilitating symptoms associated with CRSwNP. Exdensur may help redefine care for the millions of patients living with these persistent and burdensome conditions, supporting them in achieving their treatment goals with just two doses a year.”

Asthma affects more than 42 million people in Europe.³ About 5-10% of patients experience severe asthma with many continuing to experience exacerbations and reduced quality of life despite treatment.⁴ In addition, patients with CRSwNP face debilitating daily symptoms and almost half remain uncontrolled.^5,6 Exdensur is a novel therapy that combines high interleukin-5 (IL-5) binding affinity and high potency with an extended half-life, enabling the sustained suppression of disease-driving type 2 inflammation with twice-yearly dosing that could address the continued unmet need in these diseases.¹ 

Stephanie Korn, MD, PhD, Head of the Clinical Research Centre IKF Pneumologie Mainz, said: “People living with the burden of severe asthma face persistent exacerbations driven by uncontrolled type 2 inflammation. A new option with twice-yearly dosing that could provide sustained suppression of type 2 inflammation is a promising innovation for patients in Europe with severe asthma who are in urgent need of novel solutions.”

Eugenio De Corso, MD, PhD, Professor at University of Perugia, said: “CRSwNP profoundly impacts a patient’s daily life, causing debilitating nasal obstruction which can make breathing, smell, sleeping and other fundamental activities a major challenge. An innovative treatment option like Exdensur, that could help patients achieve their treatment goals in fewer doses, represents an important advance.”

In the SWIFT phase III trials treatment with depemokimab resulted in a significant 58% and 48% reduction in the rate of annualised asthma exacerbations (asthma attacks) over 52 weeks from SWIFT-1 and SWIFT-2, respectively [rate ratio (95% confidence interval) p-value: SWIFT-1 0.42 (0.30, 0.59) p<0.001 and SWIFT-2 0.52 (0.36, 0.73) p<0.001] (AER depemokimab versus placebo: SWIFT-1 0.46 vs. 1.11 and SWIFT-2 0.56 vs. 1.08 exacerbations per year).¹

In a secondary endpoint from SWIFT-1 and SWIFT-2, patients treated with depemokimab experienced numerically fewer exacerbations requiring hospitalisation and/or emergency department visits (1% and 4%) compared with placebo (8% and 10%), respectively. A pre-specified pooled analysis of the two trials showed there was a 72% reduction in the annualised rate of clinically significant exacerbations requiring hospitalisation and/or ED visits over 52 weeks for depemokimab compared with placebo [rate ratio 0.28, 95% CI (0.13, 0.61), nominal p=0.002] (AER depemokimab 0.02 versus placebo 0.09).¹ The full results from the SWIFT trials were presented at the 2024 European Respiratory Society International Conference and published in the New England Journal of Medicine.^1,7

Additionally, in the ANCHOR phase III trials, treatment with depemokimab resulted in an improvement (reduction) from baseline in nasal polyp score (scale: 0-8) at 52 weeks [treatment difference (95% confidence interval) p-value: ANCHOR-1 -0.7 (-1.1, -0.3) p<0.001 and ANCHOR-2 -0.6 (-1.0, -0.2) p=0.004] and in nasal obstruction verbal response scale (scale: 0-3) over weeks 49-52 [treatment difference (95% confidence interval) p-value: ANCHOR-1 -0.23 (-0.46, <0.00) p=0.047 and ANCHOR-2 -0.25 (-0.46, -0.03) p=0.025].² The full results from the ANCHOR trials were presented at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress and published in The Lancet.^2,8

Across these trials, depemokimab was well-tolerated, with patients experiencing a similar rate and severity of side effects as those receiving placebo.^1,2

Exdensur recently received approval in the US for the treatment of severe asthma, as well as marketing authorisation in the UK and Japan for the treatment of severe asthma and CRSwNP.^9-11  

References

1. Jackson D., et al. Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype. NEJM. September 2024. Vol. 391 No. 24.DOI: 10.1056/NEJMoa2406673.
2. Gevaert, Philippe et al. Efficacy and safety of twice per year depemokimab in chronic rhinosinusitis with nasal polyps (ANCHOR-1 and ANCHOR-2): phase 3, randomised, double-blind, parallel trials. The Lancet, Volume 405, Issue 10482, 911 – 926. DOI: 10.1016/S0140-6736(25)00197-7.
3. International Respiratory Coalition. Asthma. Available at: https://international-respiratory-coalition.org/diseases/asthma/. Accessed January 2026.
4. Menzies-Gow, A., et al. “A renewed charter: Key principles to improve patient care in severe asthma.” Advances in Therapy, vol. 39, no. 12, 17 Oct. 2022, pp. 5307-5326, https://doi.org/10.1007/s12325-022-02340-w.
5. Maspero, J, et al. “Type 2 inflammation in asthma and other airway diseases.” ERJ Open Research, vol. 8, no. 3, July 2022, pp. 00576-02021, https://doi.org/10.1183/23120541.00576-2021.
6. Seys, S, et al. “Real‐life assessment of chronic rhinosinusitis patients using mobile technology: The mysinusitiscoach project by Euforea.” Allergy, vol. 75, no. 11, 19 June 2020, pp. 2867-2878, https://doi.org/10.1111/all.14408.
7. Jackson, D, et al. “Late breaking abstract – depemokimab efficacy/safety in patients with asthma on medium/high-dose ICS: The phase IIIA randomised SWIFT-1/2 studies.” European Respiratory Journal 2024, vol. 64, no. 68, 14 Sept. 2024, https://doi.org/10.1183/13993003.congress-2024.rct3718.
8. Han, J, et al. Efficacy and Safety of Twice-Yearly Depemokimab in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP): The Phase III Randomized, Double-Blind, Placebo-Controlled Replicate ANCHOR-1/2 Trials. Journal of Allergy and Clinical Immunology, Volume 155, Issue 2, AB443. www.jacionline.org
9. “Exdensur (Depemokimab) Approved by US FDA for the Treatment of Severe Asthma.” GSK, 16 Dec. 2025, www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-us-fda-for-the-treatment-of-severe-asthma/.
10. “Exdensur (Depemokimab) Approved in the UK for Treatment of Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps.” GSK, 15 Dec. 2025, www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-the-uk-for-treatment-of-asthma-with-type-2-inflammation-and-chronic-rhinosinusitis-with-nasal-polyps/.
11. “Exdensur (depemokimab) approved in Japan for severe asthma and chronic rhinosinusitis with nasal polyps.” GSK, 6 Jan. 2026, https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-japan/.