Chinese drug regulator has approved GSK’s (NYSE:GSK) Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older.
Nucala becomes the first anti-Interleukin-5 therapy approved for use in China for adult and adolescent patients with this condition.
The approval is based on positive data from a separate phase III trial among Chinese patients in which patients receiving mepolizumab experienced 65% fewer clinically significant exacerbations compared to those who received placebo.
This is the second indication for mepolizumab in China, with approval for use in adults with eosinophilic granulomatosis with polyangiitis received in 2021.