Biopharmaceutical company GSK plc (LSE: GSK) (NYSE: GSK) announced on Monday that the US Food and Drug Administration (FDA) has accepted its submission for the use of Nucala (mepolizumab) as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. The submission, based on data from the MATINEE study, is now under review, with a Prescription Drug User Fee Act (PDUFA) date set for 7 May 2025.

The MATINEE study involved 804 COPD patients and demonstrated a significant reduction in the annualised rate of moderate to severe exacerbations when mepolizumab was added to inhaled maintenance therapy. This marks a critical step towards Nucala becoming the first biologic with monthly dosing for COPD patients.

Nucala is already approved in the US for other IL-5 mediated conditions, including severe asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES). However, this marks the first submission for COPD, which affects over 14 million people in the US alone.

COPD, the third leading cause of death globally, is a progressive disease characterised by chronic inflammation and frequent exacerbations that can lead to hospitalisation and irreversible lung damage. Nucala targets interleukin-5 (IL-5), a key cytokine involved in type 2 inflammation, which is present in up to 40% of COPD patients.

GSK's submission follows promising results from previous trials, including METREX and METREO, and aims to provide a new treatment option for patients with COPD, potentially improving outcomes and reducing the burden on healthcare systems. GSK continues to focus on advancing respiratory medicine, building on a robust pipeline of treatments aimed at modifying disease progression and improving patient quality of life.