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Exdensur (depemokimab) UK MHRA approval
GSK plc announced the UK marketing authorisation of Exdensur (depemokimab) for asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps, marking its first global approval. This ultra-long-acting biologic, administered twice yearly, demonstrated sustained efficacy in reducing asthma exacerbations by 54% and hospitalisations by 72% in Phase III trials, and improved nasal polyp scores and obstruction in CRSwNP patients. Regulatory decisions are anticipated in the US, Japan, EU, and China starting December 2025 through H1 2026. Disclaimer*
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[{"type":"text","content":"\n\nIssued: 15 December 2025, London UK\n \nExdensur (depemokimab) approved in the UK for treatment of asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps\n \n· First and only ultra-long-acting biologic with twice-yearly dosing to treat respiratory diseases\n· UK approval based on data from the SWIFT and ANCHOR phase III trials\n· Exdensur has shown sustained efficacy to reduce exacerbations, with fewer hospitalisations\n· First global approval for Exdensur, with upcoming regulatory decisions expected\nin the US, Japan, EU and China\n \n \n\nGSK plc (LSE/NYSE: GSK) today 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:\n· 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;\n· 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.\n \nThe 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\nKaivan 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 a...