BEIJING (dpa-AFX) - GSK plc (GSK), a global biopharma company on Thursday announced that the China National Medical Products Administration has accepted for review, the new drug application for the use of Nucala (mepolizumab) for patients with Chronic Obstructive Pulmonary Disease.
Mepolizumab is a monoclonal antibody that targets interleukin-5, as add-on maintenance treatment for patients with COPD with an eosinophilic phenotype.
Nucala could be the first approved biologic with monthly dosing for patients with COPD.
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.
Nucala is currently not approved for use in COPD in any country.
Nucala is currently approved for use in China across three IL-5 mediated conditions viz severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps and eosinophilic granulomatosis with polyangiitis.
COPD affects more than 390 million people globally and around 100 million people live with COPD in China, accounting for almost 25 percent of all COPD cases globally.
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