GSK plc (NYSE: GSK) has received approval for a second indication in China for its anti-interleukin-15 (IL-15) biologic, Nucala (mepolizumab). The drug is now authorized as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older.
Nucala was initially approved in China in 2021 for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA). The latest indication is supported by a Phase III trial conducted with Chinese patients, which corroborated findings from the drug’s global development program, demonstrating a 65% reduction in the annual incidence of clinically significant exacerbations (CSEs) compared to placebo.
Eosinophilic asthma is a rare subtype characterized by elevated eosinophil levels in the blood, often linked to late-onset disease and increased severity, and is typically unresponsive to steroid-based therapies. In China, approximately 46 million individuals suffer from asthma, with around 6% classified as having severe disease.- Flcube.com