GSK has announced that the European Medicines Agency (EMA) has accepted its Marketing Authorisation Application for depemokimab, an investigational monoclonal antibody targeting interleukin-5 (IL-5), for two indications: as an add-on maintenance treatment for asthma in patients aged 12 and older with type 2 inflammation characterized by an eosinophilic phenotype, and as an add-on treatment for adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

There were an estimated 262 million cases of asthma globally in 2019, with a prevalence of 27 million within Western Europe,1 which contributes to the significant burden this condition has on the lives of patients and healthcare resources. CRSwNP is a chronic condition that affects up to Nasal polyps are believed to affect up to 4% of the general adult population, and of those suffering from CRS, roughly 25–30% experience CRSwNP.²

If approved, depemokimab would be the first ultra-long-acting biologic with a six-month dosing regimen. This submission is supported by positive results from the SWIFT and ANCHOR phase III trials. The SWIFT trials, which included over 2,000 patients, demonstrated that depemokimab significantly reduced the rate of severe asthma exacerbations and hospitalizations in patients with eosinophilic asthma.³ The therapy also showed improvements in lung function and asthma control, suggesting its potential to address the long-term needs of patients with type 2 inflammation

The ANCHOR trials, which evaluated depemokimab in patients with CRSwNP, found that the treatment significantly reduced nasal polyp size and nasal congestion compared to placebo.⁴ These improvements were observed as early as week 24 and sustained over time, highlighting the potential benefit of depemokimab for patients who have not responded adequately to existing treatments

Depemokimab is currently under evaluation in phase III trials for other IL-5 mediated diseases, including eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES). As of now, depemokimab is not approved in any country.

References:

1. 1. Wang Z, Li Y, Gao Y, et al. Global, regional, and national burden of asthma and its attributable risk factors from 1990 to 2019: a systematic analysis for the Global Burden of Disease Study 2019. Respir Res. 2023;24:169–181. doi:10.1186/s12931-023-02475-6
   2. Stevens WW, Schleimer RP, Kern RC. Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2016;4:565–72.
   3. Jackson DH, Wechsler ME, Jackson DJ, eta l. Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype. N Engl J Med. 2024;391:2337–49.
   4. GSK announces positive phase III results from ANCHOR trials for depemokimab in chronic rhinosinusitis with nasal polyps. GSK Press Release. Available at: https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-phase-iii-results-from-anchor-trials/ (accessed 3 February 2025).

Disclosures: This article was created by the touchRESPIRATORY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.

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