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Depemokimab receives positive CHMP opinion
GSK plc announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of depemokimab for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP), potentially becoming the first ultra-long-acting biologic for these conditions in Europe. The positive opinion is supported by Phase III trials demonstrating statistically significant and clinically meaningful primary endpoints, including a 54% reduction in asthma exacerbations and improvements in nasal polyp scores and nasal obstruction for CRSwNP patients, with a twice-yearly dosing regimen. The European Commission's decision is anticipated in Q1 2026. Disclaimer*
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 12 December 2025, London UK\n \nDepemokimab receives positive CHMP opinion for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps\n \n· If approved, depemokimab will be the first and only ultra-long-acting biologic in the EU to treat respiratory diseases\n· Positive opinion based on four phase III trials with statistically significant and clinically meaningful primary endpoints across severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP)\n· In Europe, an estimated 3 million people live with severe asthma and patients with CRSwNP face poorly controlled symptoms\n \n \n \nGSK plc (LSE/NYSE: GSK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of 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 European Commission decision on approval is expected in Q1 2026.\n \nThe positive opinion 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. The trials support the potential for depemokimab to provide ultra-long-acting protection from asthma exacerbations as well as to alleviate symptoms associated with CRSwNP in just two doses a year.1,2\nKaivan Khavandi, SVP & Global Head, Respiratory, Immunology & Inflammation R&D, GSK said: \"Many patients with severe asthma continue to face frequent exacerbations, hospital visits and exposure to chronic oral corticosteroids, high...