USFDA accepts GSK submission for use of Nucala in COPD
London: GSK plc has announced the US Food and Drug Administration (FDA) has accepted for review, data from the MATINEE study to support the regulatory review process to obtain a new indication 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 Prescription Drug User Fee Act (PDUFA) date is 7 May 2025.
The submission is based on data from the MATINEE study, which evaluated the efficacy and safety of mepolizumab in 804 patients with COPD who have evidence of type 2 inflammation characterised by blood eosinophil count. The trial recruited COPD patients with broad clinical presentations including hard to treat patients with emphysema-only, chronic bronchitis only, or a mix of both. The MATINEE study met its primary endpoint with the addition of mepolizumab to inhaled maintenance therapy, achieving a statistically significant and clinically meaningful reduction in the annualised rate of moderate/severe exacerbations versus placebo with patients treated for 52-104 weeks.
IL-5 is a key cytokine (protein) in type 2 inflammation, an inflammatory process exhibited in up to 40% of patients with COPD and the underlying pathobiology that drives symptoms and exacerbations. Type 2 inflammation is typically detected by blood eosinophil count, a biomarker, which can be measured by a simple blood test. This test can help indicate a COPD patient’s risk of exacerbation and deterioration, their response to treatment, and inform treatment strategies in these patients.
COPD affects more than 390 million people globally and over 14 million people in the US, exerting a significant burden on healthcare resources and the lives of patients. Recurrent exacerbations add to pressures on healthcare systems and account for a large proportion of the annual direct medical costs of COPD with emergency department visits and inpatient care costing the US healthcare system around $7 billion a year.
The full results of MATINEE will be presented at a future scientific congress and form the basis of regulatory submissions around the world.
Nucala is currently approved for use in the US across four IL-5 mediated conditions. These include two respiratory indications as an add-on maintenance treatment for patients with severe asthma with an eosinophilic phenotype aged 6 years and older and as an add-on maintenance treatment for adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and inadequate response to nasal corticosteroids. Indications also include the use of Nucala for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) and for the treatment of patients ages 12 years and older with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.12 Nucala is currently not indicated for COPD anywhere in the world.
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