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Exdensur approved by the European Commission
GSK plc announced that the European Commission has approved Exdensur (depemokimab) for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP), marking the first and only ultra-long-acting biologic in the EU for respiratory diseases. The approval, based on four Phase III trials, demonstrated statistically significant and clinically meaningful primary data, showing a 58% and 48% reduction in annualised asthma exacerbations in the SWIFT trials and improvements in nasal polyp score and nasal obstruction in the ANCHOR trials. Exdensur offers a twice-yearly dosing regimen, potentially improving treatment outcomes for millions of patients with these conditions. Disclaimer*
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 17 February 2026, London UK\n \nExdensur (depemokimab) approved by the European Commission for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps \n \n· Exdensur is the first and only ultra-long-acting biologic in the EU to treat respiratory diseases\n· Approval based on four phase III trials with statistically significant and clinically meaningful primary data across severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP)\n· An estimated 3 million people live with severe asthma in Europe and patients with CRSwNP face inadequately controlled symptoms\n \n \nGSK plc (LSE/NYSE: GSK) today announced the European Commission has approved Exdensur (depemokimab) in two indications:\n· 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;\n· 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.\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\n \nKaivan 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.\"\n \nAsthma affects more than 42 million people in Europe.3 A...