Human medicines European public assessment report (EPAR): Exdensur, depemokimab, Status: Opinion

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Source: EMA New Medicines

Original: https://www.ema.europa.eu/en/medicines/human/EPAR/exdensur...

Published: Fri, 12 Dec 2025 14:00:00 +0100

Exdensur (depemokimab) is a monoclonal antibody against interleukin-5 (IL-5), intended as adjunctive maintenance therapy for patients with severe asthma with signs of type 2 inflammation (eosinophilic phenotype) aged 12 years and older who are inadequately controlled with high-dose inhaled corticosteroids plus additional control therapy[2]. Depemokimab works by preventing IL-5 from binding to its receptor, which is expected to reduce inflammation in patients with eosinophilic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP)[2]. Exdensur is administered subcutaneously as a 100 mg solution in a prefilled pen or syringe and has a very long duration of action, with dosing twice a year[2][1]. Data from the two main studies, SWIFT-1 and SWIFT-2, showed that 100 mg depemocimab significantly reduced the annual incidence of clinically significant asthma exacerbations compared with placebo; in a pooled analysis, the reduction was approximately 54% (annual incidence of 0.51 vs. 1.11 exacerbations/year)[3][2]. In the pooled secondary analysis, there was a 72% reduction in the annual incidence of exacerbations requiring hospitalization or emergency department visit (0.02 vs. 0.09 exacerbations/year)[1][3]. In the ANCHOR-1 and ANCHOR-2 trials, depemocimab demonstrated superiority to placebo in improving endoscopic nasal polyp scores and subjective assessment of nasal obstruction in patients with CRSwNP[2]. The safety profile was comparable to placebo in clinical trials, with depemokimab being well tolerated[1][2]. It is reported that GlaxoSmithKline Trading Services Limited is the holder of the drug application and the EPAR contains an assessment relevant to the approval