GSK plc (LON: GSK, NYSE: GSK) announced that the National Medical Products Administration (NMPA) has accepted another indication approval filing for its anti-interleukin-15 (IL-15) biologic Nucala (mepolizumab) for review. The UK-based company is seeking approval for the drug’s use as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.
Drug Profile
Nucala was first approved in China in 2021 to treat adults with eosinophilic granulomatosis with polyangiitis (EGPA). A second approval came in January 2023, allowing the drug to be used as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older. Most recently, Nucala was approved in July as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
Clinical Trial Results
The Phase III MATINEE study showed that Nucala significantly reduced the rate of moderate/severe exacerbations compared to placebo. If approved, Nucala would become the first biologic with monthly dosing for patients with COPD.-Fineline Info & Tech
