The European Commission approved Exdensur (depemokimab) as an add-on maintenance therapy for adults and adolescents aged 12 years and older with severe type 2 asthma uncontrolled on high-dose inhaled corticosteroids plus another controller, and as an add-on intranasal corticosteroid therapy for adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) refractory to systemic corticosteroids or surgery.

Approval was supported by SWIFT and ANCHOR phase 3 data showing sustained efficacy with twice-yearly dosing: SWIFT-1 and SWIFT-2 demonstrated 58% and 48% reductions in annualized asthma exacerbations versus standard of care, and a pooled analysis showed a 72% decrease in hospitalisations or emergency department visits for exacerbations over 52 weeks.

Asthma affects more than 42 million Europeans, with 5-10% experiencing severe disease; CRSwNP remains uncontrolled in almost half of patients despite current therapies, underscoring Exdensur’s potential to capture a significant share of both markets through improved disease control and reduced exacerbation rates.

Exdensur combines high interleukin-5 binding affinity and an extended half-life to enable twice-yearly subcutaneous dosing, aiming to enhance patient adherence and reduce the treatment burden compared with existing biologics that require more frequent administration.