FDA approves GSK's Nucala to treat COPD
GSK has gained approval from the US Food and Drug Administration (FDA) for its monoclonal antibody, Nucala (mepolizumab), as an add-on maintenance treatment for the adult population with chronic obstructive pulmonary disease (COPD) that is inadequately controlled, and an eosinophilic phenotype.
The decision is supported by positive data from the Phase III MATINEE and METREX trials, which demonstrated a significant minimisation in the annualised rate of moderate/severe exacerbation rates among patients.
Nucala targets interleukin-5 (IL-5), a cytokine involved in type 2 inflammation.
Exacerbations in COPD are critical events that can lead to irreversible damage to the lungs, worsening of symptoms and increased likelihood of death.
The goal of COPD management is to prevent such exacerbations. During the trials, the incidence of adverse events was comparable between the antibody and placebo groups.
Mepolizumab is the only approved biologic that has been assessed in individuals with an eosinophilic phenotype marked by a blood eosinophil count (BEC) threshold as low as ≥150 cells/µL (microlitre).
BEC measures eosinophil levels captured through a blood test, which helps in indicating a patient's exacerbation risk.
GSK respiratory, immunology and inflammation research and development (R&D) global head and senior vice-president Kaivan Khavandi stated: 'The approval of Nucala in the US provides an important option for COPD patients.
'Long-term follow-up studies have demonstrated that exacerbations are the single most important predictor of future risk, with particularly poor outcomes in those requiring hospital visits or admissions.'
The antibody has not yet gained approval for COPD treatment in any other country, but regulatory submissions are being reviewed in Europe and China.
It has been developed to treat a range of IL-5-mediated conditions associated with type 2 inflammation, and is approved in Europe for four such conditions and in the US for five.
In April 2025, ABL Bio and GSK entered a global licensing agreement to develop treatments for neurodegenerative conditions.
"FDA approves GSK's Nucala to treat COPD" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.
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Updated March 5, 2025. Accessed June 2, 2025. Oing C, Bristow RG. Systemic treatment of metastatic hormone-sensitive prostate cancer—upfront triplet versus doublet combination therapy. ESMO Open 2023l doi: 10.1016/ Sartor O, J. de Bono KN, Chi K, et al. Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. NEJM 2021; doi: 10.1056/NEJMoa2107322. Morris M, Castellano D, Herrmann K, et al. 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial. The Lancet 2024; doi: 10.1016/S0140-6736(24)01653-2. University of Chicago Medicine. Lutetium-177 PSMA Therapy for Prostate Cancer (Pluvicto). Accessed June 18, 2024. Jadvar H. Targeted Radionuclide Therapy: An Evolution Toward Precision Cancer Treatment [published correction appears in AJR Am J Roentgenol. 2017 Oct;209(4):949. doi: 10.2214/AJR.17.18875]. 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