GSK announced that the China National Medical Products Administration has approved Nucala (mepolizumab), as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older. Nucala is the first anti-Interleukin-5 (IL-5) targeting treatment approved for use in China for adult and adolescent patients with this condition.

Kaivan Khavandi, Senior Vice President, Global Head, Respiratory and Immunology, R&D, said: “We are delighted with this approval, supported by evidence in a Chinese population. Millions of people in China with severe eosinophilic asthma can now potentially benefit from the advance in management that Nucala could offer – a testament to GSK’s ongoing commitment to redefine respiratory disease management globally.”

The approval for use in severe asthma is based on positive data from a separate phase III trial among Chinese patients. The results from the Chinese study reinforce existing data for mepolizumab in patients with severe asthma. Adverse events were consistent with the known safety profile for mepolizumab with no new emerging safety issues specific to Chinese patients.

The global clinical development programme included four key clinical trials – DREAM9, MENSA10, SIRIUS11 and MUSCA. These trials established the efficacy and safety profile of mepolizumab in patients with severe asthma with an eosinophilic phenotype with safety data coming from pivotal, long-term and real-world studies.

This is the second indication for mepolizumab in China, with approval for use in adults with eosinophilic granulomatosis with polyangiitis (EGPA) received in 2021. Epidemiological, clinical and pathophysiological studies show that patients with EGPA usually also have asthma, which is often severe).