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New Indication Alert: GSK’s Nucala® Approved in China for CRSwNP

Jan 3, 2025

On 3 January 2025, GSK announced that China’s National Medical Products Administration (NMPA) has approved Nucala® (mepolizumab) as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.  Nucala® has previously been approved in China as an 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 an add-on maintenance treatment for patients with chronic obstructive pulmonary disease with an eosinophilic phenotype.