EC Clears GSK’s Long-acting Depemokimab for Severe Asthma

The European Commission (EC) has approved depemokimab (brand name Exdensur), an ultra-long-acting anti–interleukin-5 (IL-5) biologic developed by GSK, for two respiratory indications, add-on maintenance treatment of severe asthma with type 2 inflammation in patients aged 12 years and older and add-on therapy for adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) that is inadequately controlled by systemic corticosteroids and/or surgery.¹

The EC’s decision is supported by data from four Phase III trials (SWIFT-1, SWIFT-2, ANCHOR-1, and ANCHOR-2), each of which met their primary or co-primary endpoints with statistically significant and clinically meaningful results.^2,3 Depemokimab is administered twice yearly, positioning it as the first and only ultra-long-acting biologic for respiratory diseases approved in the European Union (EU), according to the company.¹

How did depemokimab perform in severe asthma?

The SWIFT-1 and SWIFT-2 trials evaluated depemokimab as add-on therapy in patients with severe asthma characterized by elevated blood eosinophils despite high-dose inhaled corticosteroids plus additional controller therapy. Over 52 weeks, depemokimab reduced annualized exacerbation rates by 58% in SWIFT-1 and 48% in SWIFT-2 compared with placebo (rate ratios 0.42 and 0.52, respectively; p<0.001 for both). Absolute exacerbation rates were 0.46 versus 1.11 in SWIFT-1 and 0.56 versus 1.08 in SWIFT-2.²

A pre-specified pooled analysis demonstrated a 72% reduction in clinically significant exacerbations requiring hospitalization or emergency department visits versus placebo (rate ratio 0.28; nominal p=0.002).² Across these two trials, safety findings were comparable to placebo.

“The approval of Exdensur in the EU means there is now an innovative ultra-long-acting option that offers sustained efficacy over 6 months to protect patients from severe asthma exacerbations and the debilitating symptoms associated with CRSwNP,” said Kaivan Khavandi, senior vice president and global head of Respiratory, Immunology & Inflammation R&D at GSK, in a company press release.¹

Severe asthma affects approximately 5–10% of the more than 42 million people living with asthma in Europe, with many patients continuing to experience exacerbations despite biologic therapy.^4,5

What evidence supports use in CRSwNP?

In the ANCHOR-1 and ANCHOR-2 trials, depemokimab demonstrated statistically significant improvements in nasal polyp score and nasal obstruction over 52 weeks in patients with inadequately controlled CRSwNP. At week 52, reductions in nasal polyp score were -0.7 and -0.6 versus placebo in ANCHOR-1 and ANCHOR-2, respectively. Improvements in nasal obstruction verbal response scale were also significant during weeks 49–52.³

“CRSwNP profoundly impacts a patient’s daily life, causing debilitating nasal obstruction which can make breathing, smell, sleeping and other fundamental activities a major challenge,” said Eugenio De Corso, MD, PhD, professor at the University of Perugia, in the release.¹ “An innovative treatment option like Exdensur, that could help patients achieve their treatment goals in fewer doses, represents an important advance.”

Approximately half of patients with CRSwNP remain uncontrolled despite available therapies.^6,7

What is the broader development strategy?

Depemokimab combines high IL-5 binding affinity and extended half-life to enable sustained suppression of type 2 inflammation with twice-yearly dosing. Beyond asthma and CRSwNP, the molecule is under Phase III evaluation in eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome, and chronic obstructive pulmonary disease with type 2 inflammation, according to GSK.

The EC approval follows recent regulatory decisions in the United States, United Kingdom, and Japan, expanding global access to the therapy. For the company, this decision reinforces a strategy focused on long-acting biologics targeting type 2 inflammatory pathways, with the aim of reducing exacerbation burden and treatment frequency in chronic respiratory disease.

References

1. GSK. Exdensur (depemokimab) approved by the European Commission for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps. Press Release. Feb. 17, 2026.
2. Jackson DJ, Wechsler ME, Jackson DJ, et al. Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype. NEJM. 2024;391(24). doi: 10.1056/NEJMoa2406673
3. Gevaert P, Desrosiers M, Cornet M, et al. Efficacy and safety of twice per year depemokimab in chronic rhinosinusitis with nasal polyps (ANCHOR-1 and ANCHOR-2): phase 3, randomised, double-blind, parallel trials. The Lancet 2025;405(10482): 911–926. doi: 10.1016/S0140-6736(25)00197-7
4. Asthma. International Respiratory Coalition. https://international-respiratory-coalition.org/diseases/asthma/. Accessed Feb. 17, 2026.
5. Menzies-Gow A, Jackson DJ, Al-Ahmad M, et al. A renewed charter: Key principles to improve patient care in severe asthma. Adv. Ther. 2022;39(12):5307–5326. doi: 10.1007/s12325-022-02340-w
6. Maspero J, Adir Y, Al-Ahmad M, et al. Type 2 inflammation in asthma and other airway diseases. ERJ Open Research 2022;8(3): 00576–02021. doi: 10.1183/23120541.00576-2021
7. Seys S, De Bont S, Fokkens WJ, et al. Real‐life assessment of chronic rhinosinusitis patients using mobile technology: The mysinusitiscoach project by Euforea. Allergy 2020:75(11): 2867–2878. doi: 10.1111/all.14408