GSK plc has secured approval from the European Commission for Exdensur (depemokimab) in two indications: as an add-on maintenance treatment for severe asthma with type 2 inflammation in patients aged 12 years and older, and as an add-on therapy for adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) inadequately controlled by systemic corticosteroids and/or surgery.

The approval is supported by data from the Phase III SWIFT and ANCHOR clinical trial programmes, where depemokimab demonstrated sustained efficacy with a twice-yearly dosing regimen. Across the four pivotal studies, the drug met its primary or co-primary endpoints with statistically significant and clinically meaningful results compared with standard of care alone.

In the SWIFT-1 and SWIFT-2 trials involving patients with severe asthma, depemokimab reduced annualised asthma exacerbations by 58 percent and 48 percent, respectively, over 52 weeks versus placebo. A pooled analysis showed a 72 percent reduction in exacerbations requiring hospitalisation or emergency department visits. The findings were previously presented at the European Respiratory Society International Conference and published in the New England Journal of Medicine.

In the ANCHOR-1 and ANCHOR-2 trials in CRSwNP, depemokimab significantly improved nasal polyp scores and reduced nasal obstruction symptoms at 52 weeks compared with placebo. These results were presented at the American Academy of Allergy, Asthma and Immunology and World Allergy Organisation Joint Congress and published in The Lancet.

Kaivan Khavandi, Senior Vice President and Global Head of Respiratory, Immunology and Inflammation R&D at GSK, said the EU approval provides patients with an innovative ultra-long-acting treatment option that delivers sustained efficacy over six months, potentially redefining care for individuals living with severe asthma and CRSwNP.

Asthma affects more than 42 million people in Europe, with approximately 5–10 percent experiencing severe disease. CRSwNP remains inadequately controlled in nearly half of affected patients, despite available treatments. Depemokimab, an ultra-long-acting biologic targeting interleukin-5 (IL-5), is designed to suppress disease-driving type 2 inflammation through twice-yearly dosing.

Across the trials, depemokimab was generally well tolerated, with safety outcomes comparable to placebo. The therapy has also received approval in the United States for severe asthma and marketing authorisation in the UK and Japan for both severe asthma and CRSwNP.

Depemokimab continues to be evaluated in additional Phase III trials for eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome and chronic obstructive pulmonary disease with type 2 inflammation.