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The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use has recommended the granting of a marketing authorization for Exdensur (depemokimab, GlaxoSmithKline) for severe eosinophilic asthma and severe chronic rhinosinusitis with nasal polyps.
Exdensur, a long-acting antibody treatment, will be available as a 100-mg solution for injection in a prefilled pen or syringe for subcutaneous administration.
It is indicated as add-on maintenance treatment for severe asthma with type 2 inflammation characterized by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite a high dose of inhaled corticosteroids plus another asthma controller. It is also indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyps for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.
The main evidence of the efficacy of Exdensur in severe asthma is based on two replicate phase 3 clinical studies, SWIFT-1 and SWIFT-2, which showed superiority of 100 mg depemokimab over the placebo (in addition to the standard of care) in the annualized rate of clinically significant exacerbations among patients aged 12 years and older with uncontrolled severe asthma with an eosinophilic phenotype.
The main evidence of efficacy of Exdensur in severe chronic rhinosinusitis with nasal polyps is based on two replicate phase 3 studies, ANCHOR-1 and ANCHOR-2, which showed superiority of 100 mg depemokimab over the placebo (in addition to the standard of care) in the endoscopic nasal polyps score and nasal obstruction verbal rating score among patients with symptomatic and severe disease.
Detailed recommendations for the use of this product will be published on the EMA website after the marketing authorization has been granted by the European Commission.
