The European Commission has approved Exdensur (depemokimab), a new ultra-long-acting biologic from GSK plc, for the treatment of severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP), marking the first therapy of its kind in the European Union for respiratory diseases.
The approval covers two indications. Exdensur is authorised as an add-on maintenance treatment for adults and adolescents aged 12 years and older with severe asthma characterised by elevated blood eosinophils who remain inadequately controlled despite high-dose inhaled corticosteroids and at least one additional controller therapy.
It is also approved as an add-on therapy to intranasal corticosteroids for adults with severe CRSwNP whose disease is not adequately controlled by systemic corticosteroids and/or surgery.
Regulatory clearance is based on results from four phase III trials — SWIFT-1, SWIFT-2, ANCHOR-1 and ANCHOR-2 — in which depemokimab met all primary or co-primary endpoints with statistically significant and clinically meaningful outcomes compared with standard of care alone. Across the programme, the therapy demonstrated sustained efficacy with a twice-yearly dosing schedule.
In the SWIFT asthma trials, which enrolled a combined 762 patients with severe asthma receiving medium- to high-dose inhaled corticosteroids plus additional controllers, depemokimab significantly reduced annualised asthma exacerbations over 52 weeks. Exacerbation rates were reduced by 58% in SWIFT-1 and 48% in SWIFT-2 compared with placebo. The therapy also showed a substantial reduction in clinically significant exacerbations requiring hospitalisation or emergency department visits in pooled analyses. Full SWIFT data were presented at the 2024 European Respiratory Society International Conference and published in the New England Journal of Medicine.
The ANCHOR trials evaluated 528 patients with inadequately controlled CRSwNP, all of whom had bilateral nasal polyps and a history of surgery, systemic corticosteroid use or intolerance. Patients receiving depemokimab every six months alongside standard intranasal corticosteroids experienced significant reductions in nasal polyp score and improvements in nasal obstruction severity at 52 weeks compared with placebo.
Results from ANCHOR were presented at the 2025 American Academy of Allergy, Asthma and Immunology and World Allergy Organization Joint Congress and published in The Lancet.
Across all studies, depemokimab was generally well tolerated, with adverse event rates and severity comparable to placebo.
Asthma affects more than 42 million people in Europe, with an estimated 5–10% experiencing severe disease. Approximately three million people are living with severe asthma across the region, many of whom continue to suffer frequent exacerbations despite existing therapies. Patients with CRSwNP often experience persistent nasal obstruction, impaired sense of smell and reduced quality of life, and nearly half remain inadequately controlled.
Depemokimab is designed to target interleukin-5 (IL-5), a key cytokine driving type 2 inflammation. The biologic combines high IL-5 binding affinity and potency with an extended half-life, enabling dosing once every six months. The approval makes Exdensur the first and only ultra-long-acting biologic in the EU for respiratory conditions linked to type 2 inflammation.
Exdensur has also recently received approval in the United States for severe asthma and marketing authorisation in the United Kingdom and Japan for both severe asthma and CRSwNP.
Beyond these indications, depemokimab is being evaluated in additional phase III trials for eosinophilic granulomatosis with polyangiitis (OCEAN), hypereosinophilic syndrome (DESTINY), and in three studies — ENDURA-1, ENDURA-2 and VIGILANT — assessing its role as an add-on therapy in patients with uncontrolled moderate to severe chronic obstructive pulmonary disease with type 2 inflammation.
The European authorisation expands treatment options for patients with severe inflammatory respiratory diseases and introduces a twice-yearly biologic approach aimed at sustained disease control.
