GSK's depemokimab approved in EU for severe asthma and nasal polyps

GSK plc announced that the European Commission has approved Exdensur (depemokimab) for two indications. It will be used as an add-on maintenance treatment for adults and adolescents aged 12 and older with severe asthma and type 2 inflammation who are not adequately controlled by high-dose inhaled corticosteroids plus another controller medication. The approval also covers its use as an add-on therapy with intranasal corticosteroids for adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) inadequately controlled by systemic corticosteroids and/or surgery.

Exdensur is the first and only ultra-long-acting biologic approved in the EU for respiratory diseases. The approval stems from four Phase III trials (SWIFT and ANCHOR) which demonstrated sustained efficacy with a twice-yearly dosing regimen. Data showed depemokimab significantly reduced the rate of asthma exacerbations and improved symptoms in CRSwNP patients.

Approximately three million people in Europe live with severe asthma, many experiencing frequent exacerbations and reduced quality of life despite treatment. Patients with CRSwNP also face significant symptom burden. GSK suggests the new twice-yearly treatment can improve care for these patients by providing sustained control of inflammation with only two doses annually.