The European Commission granted marketing authorisation for Exdensur (depemokimab) as an add-on maintenance treatment for adults and adolescents (12+) with severe type 2 asthma uncontrolled on high-dose inhaled corticosteroids plus another controller. It also approved Exdensur as add-on therapy with intranasal corticosteroids for adults with severe chronic rhinosinusitis with nasal polyps not adequately managed by systemic corticosteroids or surgery.

In the SWIFT-1 and SWIFT-2 studies, twice-yearly depemokimab dosing delivered 58% and 48% reductions, respectively, in annualised asthma exacerbations over 52 weeks versus standard of care. A pooled analysis showed a 72% cut in clinically significant exacerbations requiring hospitalisation or emergency visits. In ANCHOR trials, Exdensur also produced meaningful decreases in nasal polyp scores and nasal obstruction metrics at week 52.

Asthma affects over 42 million Europeans, with 5–10% experiencing severe disease and ongoing exacerbations despite therapy. Chronic rhinosinusitis with nasal polyps imposes daily symptom burden on nearly half of patients who remain uncontrolled. Exdensur’s extended half-life and twice-yearly regimen aim to improve adherence and reduce treatment gaps in these high-need populations.

Following US approval in December 2025 and recent authorisations in the UK and Japan, the EU approval positions Exdensur as GSK’s key respiratory biologic. GSK plans to integrate Exdensur into its European launch strategy later this year, targeting revenue growth in its specialty care franchise and reinforcing its leadership in severe asthma and nasal polyp treatment.