GSK plc (LSE/NYSE: GSK) has announced the marketing authorisation of Exdensur (depemokimab) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). In the UK, Exdensur is now approved in two indications:
· as an add-on maintenance treatment of asthma in adult and adolescent patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype who are inadequately controlled on maximum moderate-dose or 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 chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate 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: “Today’s UK approval of Exdensur, the first in the world, has the potential to redefine care for millions of patients. This ultra-long-acting biologic delivers sustained efficacy to reduce asthma exacerbations, keep patients out of hospital and help prevent cumulative lung damage in just two doses a year. This is a step change in respiratory treatment, and we look forward to additional regulatory decisions expected in the US, Japan, EU and China.”
Asthma affects more than 260 million people globally3 and about 7 million people in the UK,4 a portion of whom have type 2 inflammation characterised by an eosinophilic phenotype.5 Approximately half continue to experience symptoms and exacerbations despite treatment.6 Asthma exacerbations place a significant resource burden on healthcare systems due to emergency department visits and hospitalisations, with an estimated 22% increase in NHS costs by 2031.7 With the potential to reduce asthma exacerbations, including those leading to hospitalisations, and alleviate the debilitating symptoms associated with CRSwNP, Exdensur could improve patient outcomes while contributing to a reduction in health system burden.
The pooled results from the SWIFT trials showed a 54% reduction in clinically significant exacerbations (asthma attacks) over 52 weeks [rate ratio 0.46, 95% confidence interval (0.36, 0.59), nominal p<0.001] (AER depemokimab = 0.51 exacerbations per year versus placebo = 1.11).1 Additionally, this pooled analysis showed a 72% reduction [RR 0.28, 95% CI (0.13, 0.61), nominal p=0.002] (AER: depemokimab = 0.02 versus placebo = 0.09) in the secondary endpoint of clinically significant exacerbations requiring hospitalisation or emergency department visit compared to placebo.1 In AGILE, an open-label 12-month extension study, depemokimab maintained the results seen in SWIFT-1 and SWIFT-2, confirming the sustained safety and efficacy of a twice-yearly dose of depemokimab over the course of two years.
Pooled results from the ANCHOR trials showed an improvement (reduction) from baseline in nasal polyp score (scale: 0-8) at 52 weeks [treatment difference -0.7, 95% CI (-0.9, -0.4), nominal p<0.001] and in nasal obstruction verbal response scale (scale: 0-3) over weeks 49-52 [treatment difference -0.24, 95% CI (-0.39, -0.08), nominal p=0.003].2
Across these trials, depemokimab was well-tolerated, with patients experiencing a similar rate and severity of side effects as those receiving placebo.1,2
Depemokimab recently received a positive CHMP opinion in the EU and it is currently under regulatory review in other countries, including in the US, Japan and China. Decisions on these approvals are expected starting in December 2025 and continuing through H1 2026.
References
- 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.
- 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.
- World Health Organisation. Asthma Key Facts. Available at: https://www.who.int/news-room/fact-sheets/detail/asthma. Accessed December 2025.
- Office for Health Improvement & Disparities. Respiratory disease profile: statistical commentary, June 2025. Available at: https://www.gov.uk/government/statistics/update-of-indicators-in-the-respiratory-disease-profile-june-2025/respiratory-disease-profile-statistical-commentary-june-2025. Accessed December 2025.
- “What Is Type 2 Inflammation?” Allergy & Asthma Network, 22 May 2025, https://allergyasthmanetwork.org/health-a-z/type-2-inflammation-resources/. Accessed December 2025.
- Menzies-Gow, Andrew et al. “A Renewed Charter: Key Principles to Improve Patient Care in Severe Asthma.” Advances in therapy vol. 39,12 (2022): 5307-5326. doi:10.1007/s12325-022-02340
- Orlovic M, Tzelis D, Guerra I, Bar-Katz V, Woolley N, Bray H, Hanslot M, Usmani O, Madoni A. Environmental, healthcare and societal impacts of asthma: a UK model-based assessment. ERJ Open Res. 2024 Jul 22;10(4):00577-2023. doi: 10.1183/23120541.00577-2023. PMID: 39040585; PMCID: PMC11261382.
