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GSK’s Nucala® (Mepolizumab) Under Review in China for COPD

Feb 20, 2025

On 20 February 2025, GSK announced that China’s National Medical Products Administration (NMPA) has accepted for review a new drug application for the use of Nucala® (mepolizumab) as add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.  According to GSK, if approved, Nucala® could be the first approved biologic with monthly dosing for patients with COPD.

Nucala® has been approved in China for a number of indications, including as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) (January 2025), and as add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older (January 2024).

In December 2024, GSK announced that the US FDA accepted for review data to support a new indication for the use of Nucala® as add-on maintenance treatment for patients with COPD with an eosinophilic phenotype.