The US Food and Drug Administration (FDA) has accepted a submission from GSK to review a new indication of Nucala (mepolizumab) as an add-on maintenance treatment for chronic obstructive pulmonary disease (COPD) in individuals with an eosinophilic phenotype.
GSK’s submission is supported by data from the MATINEE study, which assessed the therapy's safety and efficacy. The study involved 804 COPD patients exhibiting type 2 inflammation, as indicated by blood eosinophil count.
The study's diverse patient group included subjects with clinical presentations including emphysema, chronic bronchitis, or a combination of both.
MATINEE achieved its primary endpoint, showing that adding mepolizumab to inhaled maintenance therapy significantly reduced the annualised rate of moderate/severe exacerbations compared to placebo, with subjects treated for 52 to 104 weeks.
The outcomes are expected to form the basis of regulatory submissions worldwide.
Nucala is already approved in the US for four IL-5-mediated conditions, including severe asthma and chronic rhinosinusitis with nasal polyps, but is not currently indicated for COPD treatment anywhere globally.
COPD is a global health issue, affecting more than 390 million people, and more than 14 million in the US.
Type 2 inflammation is observed in numerous immuno-inflammatory disorders and serves as the fundamental pathology that contributes to symptoms and exacerbations in up to 40% of individuals with COPD.
Inflammation is generally identified by measuring blood eosinophil levels, a specific biomarker that can be evaluated through a blood test. This assessment can provide insights into a COPD patient's likelihood of experiencing exacerbations and worsening of their condition and guide the development of treatment plans.
The Prescription Drug User Fee Act (PDUFA) date for the potential new indication is 7 May 2025.
In November 2024, the European Commission approved a single-vial, fully liquid presentation of the company’s Menveo vaccine (MenACWY), aimed at protecting against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y.
