GSK Nucala application for COPD accepted for review in China
GSK plc has 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. 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, with research estimating that approximately 100 million people in China live with COPD, which accounts for almost 25% of the global COPD cases. 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. This burden is expected to dramatically increase due to the rapidly aging population in China.
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