GSK application to expand use of Nucala for COPD accepted for review by EMA

The application is supported by results from the positive phase III MATINEE trial, which showed a statistically significant and clinically meaningful reduction in the annualised rate of moderate/severe exacerbations with mepolizumab compared to placebo. The trial recruited patients across a wide spectrum of COPD phenotypes and clinical presentations. These data indicate that mepolizumab, in addition to inhaled maintenance therapy, offers a clinically meaningful benefit to a patient population in need of treatments to reduce their risk of exacerbations. Results of MATINEE will be presented at a future scientific congress.

IL-5 is a key cytokine (protein) in type 2 inflammation which is an underlying driver in many diseases. This type of inflammation is detected in up to 40% of patients with COPD and is a major cause of symptoms and exacerbations that can lead to hospitalisation and/or emergency room visits.

COPD affects more than 390 million people globally and over 40 million people in Europe. It is one of the leading causes of hospitalisation in many countries. In 2021 alone, COPD had a societal cost of approximately 164 billion euros and resulted in more than 330,000 deaths in Europe. Recurrent exacerbations accelerate disease progression and further increase the risk of hospitalisation, adding to pressures on healthcare systems through emergency department visits and inpatient care.

"If approved, mepolizumab could be the first biologic with monthly dosing for patients with COPD," the Company stated.

First approved in 2015 for severe asthma with an eosinophilic phenotype in the US, mepolizumab is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2 inflammation.

Mepolizumab is currently approved for use in Europe across four IL-5 mediated conditions. These include two respiratory indications as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older and as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyps for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. Indications also include the use of mepolizumab as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA) and as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Mepolizumab is currently not approved for use in COPD in any country.