UK pharmaceutical giant GlaxoSmithKline (GSK, LON: GSK, NYSE: GSK) has announced the official market launch in China of its monoclonal antibody Nucala (mepolizumab) for the treatment of adult eosinophilic granulomatosis with polyangiitis (EGPA). This move expands the drug’s availability to patients in China, offering a new therapeutic option for this rare condition.
Regulatory Milestones
Mepolizumab made history as the world’s first IL-5 monoclonal antibody when it was approved in the US in November 2015 for severe eosinophilic asthma in patients aged 12 and older. The indication was later expanded in September 2019 to include children aged 6 to 9. In China, the drug received clinical trial approval for chronic obstructive pulmonary disease (COPD) in March 2020 and gained its first approval for adult EGPA treatment in November 2021.
Approved Indications
Mepolizumab has been approved in the US and other countries for several conditions related to eosinophilic inflammation, including severe eosinophilic asthma (SEA), EGPA, hypereosinophilic syndrome (HES), and chronic rhinosinusitis with nasal polyps (CRSwNP). Its mechanism of action targets interleukin-5 (IL-5), a key driver of eosinophilic inflammation in these conditions.-Fineline Info & Tech
