First Ultra-Long-Acting Biologic Approved in Europe for Severe Asthma and CRSWNP
The European Commission has approved depemokimab, a novel biologic therapy, for two distinct indications: severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps (CRSWNP). This marks a significant advancement in respiratory disease management, offering a new treatment option with an ultra-long-acting dosing regimen.
What is Depemokimab?
Depemokimab is the first and only ultra-long-acting biologic in the European Union approved for these indications. It is designed as an add-on maintenance treatment for severe asthma in adults and adolescents (12 years and older) whose condition is not adequately controlled with high-dose inhaled corticosteroids (ICS) plus another asthma controller. For CRSWNP, it’s indicated as an add-on therapy with intranasal corticosteroids for adult patients whose disease isn’t well-managed by systemic corticosteroids and/or surgery. La Milano reported on this approval February 17, 2026.
Clinical Trial Results
The approval is based on data from Phase III Swift and Anchor studies. These studies demonstrated sustained efficacy with a twice-yearly dosing schedule of depemokimab. Both studies met their primary or co-primary endpoints, showing statistically and clinically significant improvements when depemokimab was added to standard care compared to standard care alone. An open-label extension study lasting 12 months further confirmed the treatment’s effectiveness and safety, suggesting a potential cumulative effect with progressive improvements over time.
Impact on Patients
According to Cristiano Caruso, director of the UOSD Allergology and Clinical Immunology Fondazione Policlinico A. Gemelli Irccs Roma – Università Cattolica del Sacro Cuore, depemokimab represents an significant turning point in managing complex patients with high care needs. Adnkronos Health reported on January 30, 2026, that the drug has shown a statistically significant reduction in both severe and moderate exacerbations, as well as hospitalizations and emergency room visits.
The drug’s innovative dosing schedule – every six months – is expected to significantly improve therapeutic adherence and patients’ quality of life. It likewise aims to modify the course of the disease, rather than just controlling symptoms.
Addressing a Significant Clinical Need
Approximately 3 million people in Europe suffer from severe asthma and around 60% of these patients also have chronic rhinosinusitis with nasal polyposis, according to data from the Severe Asthma Network Italy. This comorbidity significantly contributes to exacerbations and re-hospitalizations. Depemokimab is designed to treat this large patient population in an integrated way.
Future Research
Clinical research is ongoing to evaluate the use of depemokimab in other conditions characterized by eosinophilic inflammation, including eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndromes. The goal is to develop a therapeutic strategy that can address all pathologies supported by type 2 inflammation with high levels of eosinophils and interleukin 5.