Pharma Focus Asia

GSK Announces China National Medical Products Administration Acceptance for Nucala (mepolizumab)

Wednesday, March 15, 2023

GSK announced that the China National Medical Products Administration has accepted for review a new drug application for Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma (SEA). If approved, Nucala would be the first targeted anti-Interleukin-5 (IL-5) treatment in China for adult and adolescent patients with this condition.

Nucala is currently approved in China for use in adults with eosinophilic granulomatosis with polyangiitis (EGPA) and was included on the National Reimbursement Drug List in January 2023. Nucala is not currently approved in China for the treatment of SEA.   

Nucala is the first-in-class monoclonal antibody to target IL-5. It works by preventing IL-5 from binding to its receptor on the surface of eosinophils, reducing blood eosinophils and maintaining them within normal levels. Nucala has been studied in over 4,000 patients in 41 clinical trials across several eosinophilic indications and was the first treatment approved in the US across four eosinophil-driven diseases: SEA, EGPA, hypereosinophilic syndrome and chronic rhinosinusitis with nasal polyps. Nucala has been approved in the US, the European Union and over 25 other markets, as an add-on maintenance treatment for patients with SEA.

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