By VETTAPHARMA reporter: The European Commission has granted marketing authorization for Exdensur (depemokimab), a twice-yearly biologic therapy developed by GSK plc for people with respiratory diseases marked by persistent type 2 inflammation — notably severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). This approval marks a milestone in respiratory medicine in the European Union, offering an extended-duration treatment option for patients whose conditions remain inadequately controlled despite existing therapies.
Under the EC authorization, Exdensur is indicated as:
an add-on maintenance treatment for severe asthma in adults and adolescents aged 12 years and older with type 2 inflammation who remain uncontrolled despite high-dose inhaled corticosteroids plus another controller; and an add-on therapy with intranasal corticosteroids for adults with severe CRSwNP when systemic corticosteroids and/or surgery have not achieved adequate disease control.
The regulatory decision is supported by robust outcomes from four phase III clinical trials (SWIFT-1, SWIFT-2, ANCHOR-1 and ANCHOR-2). All trials met their primary or co-primary endpoints, demonstrating statistically significant and clinically meaningful improvements when Exdensur was added to standard care versus standard care alone.
Noteworthy results from the SWIFT asthma trials include:
- 58% and 48% reductions in annualized asthma exacerbation rates over 52 weeks in the SWIFT-1 and SWIFT-2 studies, respectively, compared with placebo;
- fewer exacerbations requiring hospitalization or emergency care in patients receiving depemokimab; and
- a 72% reduction in clinically significant exacerbations leading to hospital/emergency visits in a pooled analysis.
In the ANCHOR trials for CRSwNP, patients treated with Exdensur experienced significant improvements in nasal polyp score and nasal obstruction measures compared with placebo at one year.
Across studies, depemokimab was well-tolerated, with side-effect profiles similar to placebo.
GSK’s Kaivan Khavandi, Global Head of Respiratory, Immunology & Inflammation R&D, stated that the approval introduces an “innovative ultra-long-acting option” intended to provide sustained protection against severe asthma exacerbations and debilitating CRSwNP symptoms with just two doses per year.
Asthma affects an estimated 42 million people in Europe, with roughly 5-10% experiencing severe disease despite treatment, while nearly half of CRSwNP patients remain uncontrolled on existing therapy — underscoring the unmet medical need Exdensur aims to address.
Exdensur has already been approved in the United States, United Kingdom, and Japan for similar respiratory indications, highlighting the global momentum behind this new treatment approach.
Source credit:
- GSK. (2026, February 17). Exdensur (depemokimab) approved by the European Commission for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps. GSK Press Release. Click here
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