GSK plc (LSE/NYSE: GSK) today announced that the China National Medical Products Administration has accepted for review the new drug application for the use of Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.
IL-5 is a key cytokine (protein) in type 2 inflammation which is an underlying driver in many diseases. 2-4 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.2-4
COPD affects more than 390 million people globally, with research estimating that approximately 100 million people in China live with COPD, which accounts for almost 25% of the global COPD cases.5,6 This puts a significant burden on healthcare resources and the lives of patients, with recurrent exacerbations accounting for a large proportion of the annual direct medical costs of COPD due to emergency department visits and inpatient care.5-7 This burden is expected to dramatically increase due to the rapidly aging population in China.6,7
Nucala’s application was supported by results from the positive Phase III MATINEE trial which showed a significant and clinically meaningful reduction in rate of moderate/severe exacerbations with Nucala compared to placebo. The trial recruited a wide spectrum of COPD patients including those with chronic bronchitis, emphysema-only or both.1 These data indicate that Nucala, 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.
If approved, Nucala could be the first approved biologic with monthly dosing for patients with COPD.
Nucala is currently approved for use in the China across three IL-5 mediated conditions. These include two respiratory indications as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older and as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with 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 Nucala for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
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.8 Nucala has been developed for the treatment of a range of IL-5 mediated diseases associated with type 2 inflammation.8
The mepolizumab programme in COPD is comprised of three clinical trials. The first two studies, METREX and METREO, completed in 2017. MATINEE was designed to supplement METREX and METREO, building on our learnings from these studies and IL-5 science to identify the patients who could benefit the most from Nucala and support future submissions and approvals for use in this indication.9
MATINEE is a phase III, randomized (1:1), double-blind, parallel-group trial assessing the efficacy and safety of mepolizumab 100 mg as add-on therapy, administered subcutaneously every 4 weeks for 52–104 weeks, versus placebo in addition to inhaled triple therapy (dual long-acting bronchodilators plus inhaled corticosteroid) in 804 patients with COPD, a history of exacerbations, and evidence of type 2 inflammation characterised by raised blood eosinophil count.1
The primary endpoint was met with the addition of Nucala to inhaled maintenance therapy, showing a statistically significant and clinically meaningful reduction in the annualised rate of moderate/severe exacerbations versus placebo with patients treated for 52-104 weeks.
Data from MATINEE will be presented at a future scientific congress or in a peer reviewed journal. Global regulatory submissions including MATINEE data are ongoing.
