GSK: seeks approval for Nucala from China
(CercleFinance.com) - GSK reports that China's State Administration of Medical Products has agreed to review a new drug application for Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma (SEA).
The application is based on positive data from a Phase III trial in Chinese patients and the global EAS development program, which included three pivotal clinical trials that established the efficacy and safety profile of mepolizumab for severe eosinophilic asthma patients.
GSK says that asthma affects approximately 46 million adults in China, of which 6% suffer from severe asthma.
Nucala is currently approved in China for use in adults with eosinophilic granulomatosis with polyangiitis (EGPA) and was listed on the national reimbursement list in January 2023, although is not currently approved in China for the treatment of EAS.
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