New Long-Acting Biologic Advances Care for Severe Asthma
A newly approved antibody therapy targets eosinophilic inflammation in asthma and nasal polyps with infrequent dosing and strong phase 3 evidence.
A long-acting biologic antibody, depemokimab, has received a positive recommendation from European regulators for severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps, showing meaningful reductions in exacerbations and symptom burden when added to standard therapy.
Study Details
Severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps are both driven by type 2 inflammation, a pathway characterized by elevated eosinophils and cytokines such as interleukin-5. Many patients remain poorly controlled despite high-dose inhaled steroids, additional controller medications, systemic steroids, or repeated sinus surgery.
Depemokimab is a long-acting monoclonal antibody designed to suppress eosinophilic inflammation over extended intervals. The European Medicines Agency Committee for Medicinal Products for Human Use has now recommended marketing authorization for depemokimab under the brand name Exdensur for both conditions.
The therapy is intended as an add-on maintenance option for patients who continue to experience significant disease activity despite current best-in-class treatments.
Methodology
The regulatory recommendation is based on four large phase 3 randomized controlled trials.
For severe asthma, the SWIFT-1 and SWIFT-2 studies enrolled adolescents and adults aged 12 years and older with uncontrolled severe eosinophilic asthma. Participants received either depemokimab 100 mg or placebo, in addition to standard asthma therapy, and were followed for clinically significant exacerbations.
For chronic rhinosinusitis with nasal polyps, the ANCHOR-1 and ANCHOR-2 studies enrolled adults with severe, symptomatic disease despite intranasal corticosteroids and prior systemic steroids or surgery. Outcomes included objective endoscopic polyp scores and patient-reported nasal obstruction.
All trials compared depemokimab against placebo on top of standard care.
Key Findings
Depemokimab significantly reduced the annualized rate of clinically significant asthma exacerbations compared with placebo in patients with eosinophilic asthma
Improvements were observed across both adolescent and adult asthma populations receiving high-dose background therapy
In nasal polyps, depemokimab led to meaningful reductions in endoscopic polyp size
Patients reported improved nasal obstruction scores compared with placebo
Benefits were demonstrated consistently across replicate phase 3 trials for both conditions
Implications for Practice
For patients, this approval introduces a potential new option that targets the underlying inflammatory driver of disease rather than only treating symptoms. The long-acting nature of depemokimab may reduce treatment burden compared with more frequent injection schedules, which could improve adherence for some individuals with severe disease.
For clinicians, depemokimab adds to the expanding biologic landscape for type 2 inflammatory airway disease. Its demonstrated efficacy across two related but distinct conditions highlights the shared biology of eosinophilic asthma and nasal polyps. Careful patient selection remains critical, particularly confirmation of eosinophilic inflammation and inadequate control on existing therapies.
Regulatory approval by the European Commission would formalize its role as an add-on option alongside other biologics targeting similar pathways, with future real-world data likely to clarify positioning, durability of response, and comparative effectiveness.