GSK’s Exdensur (depemokimab) approved by EU for severe asthma & CRSwNP. Twice-yearly dosing cuts exacerbations 48-58%. Learn trial data & expert insights.
Written By: Dr. Pavan Kumar Chikkula PharmD and Dharan PharmD
Reviewed By: Pharmacally Editorial Team
GSK plc announced that the European Commission has approved Exdensur (depemokimab) for severe asthma with type 2 inflammation and severe chronic rhinosinusitis with nasal polyps (CRSwNP). This ultra-long-acting biologic offers twice-yearly dosing, addressing unmet needs in these conditions.
Kaivan Khavandi, GSK SVP of Respiratory R&D, highlighted Exdensur’s potential to redefine care with sustained efficacy over six months and just two annual doses. Stephanie Korn, MD, PhD, noted its promise for suppressing type 2 inflammation in severe asthma, while Eugenio De Corso, MD, PhD, emphasized relief from CRSwNP’s daily burdens like nasal obstruction.
Approval Indications
Exdensur is approved as an add-on maintenance treatment for severe asthma characterized by elevated blood eosinophil counts in adults and adolescents aged 12 years and older inadequately controlled on high-dose inhaled corticosteroids (ICS) plus another controller. It is also approved as add-on therapy with intranasal corticosteroids for adults with severe CRSwNP unresponsive to systemic corticosteroids or surgery.
Trial Data Highlights
The approval relies on the SWIFT and ANCHOR phase III trials, where depemokimab met primary endpoints with significant reductions in asthma exacerbations and CRSwNP symptoms versus standard of care. In SWIFT-1 and SWIFT-2, depemokimab reduced annualized exacerbation rates by 58% and 48% over 52 weeks (rate ratios: 0.42, p<0.001; 0.52, p<0.001), with a 72% drop in severe events requiring hospitalization/ED visits in pooled analysis.
For ANCHOR-1 and ANCHOR-2, it improved nasal polyp scores by -0.7 and -0.6 points (p<0.001, p=0.004) and nasal obstruction scores by -0.23 and -0.25 points (p=0.047, p=0.025). Safety profiles matched placebo across studies.
Disease Burden and Pipeline
Asthma impacts over 42 million Europeans, with 5-10% severe cases uncontrolled despite treatment; nearly half of CRSwNP patients remain symptomatic. Exdensur targets IL-5 for type 2 inflammation suppression. Ongoing trials include OCEAN for EGPA, DESTINY for HES, and ENDURA/VIGILANT for COPD.
Global Approvals
Exdensur recently received US approval for severe asthma, plus UK and Japan authorizations for asthma and CRSwNP. EU product information is at the EMA site.
Reference
Exdensur (depemokimab) approved by the European Commission for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps, 17 February 2026, Exdensur (depemokimab) approved by the European Commission for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps | GSK
David J. Jackson et al, Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype, N Engl J Med 2024;391:2337-2349, DOI: 10.1056/NEJMoa2406673
Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype (SWIFT-1), ClinicalTrials.gov ID NCT04719832, Study Details | NCT04719832 | Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype | ClinicalTrials.gov
A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype (SWIFT-2), ClinicalTrials.gov ID NCT04718103, Study Details | NCT04718103 | A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype | ClinicalTrials.gov
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, https://doi.org/10.1016/S0140-6736(25)00197-7
Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-1), ClinicalTrials.gov ID NCT05274750, Study Details | NCT05274750 | Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps | ClinicalTrials.gov
Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2) (ANCHOR-2), ClinicalTrials.gov ID NCT05281523, Study Details | NCT05281523 | Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2) | ClinicalTrials.gov