GSK plc (LSE/NYSE: GSK) today 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.
Asthma is a major health burden in China affecting an estimated 46 million adults.1 Of those, approximately 6% experience severe asthma, which confers the most substantial impact on daily living, is associated with an increased risk of exacerbations requiring hospitalisation, and higher likelihood of potentially fatal asthma attacks.1-5 In China, 15.5% of people with asthma have experienced an exacerbation requiring a hospital visit in the preceding 12 months.1
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.”
Guidelines for bronchial asthma prevention and management (2020 edition) from the Asthma group of the Chinese Thoracic Society reference the current unmet need among Chinese patients with this condition.6 The guidelines also reference evidence for targeted biologic therapy that could reduce exacerbations, emergency or hospitalisation rates, oral corticosteroid use, and also improve asthma control and lung function.6
The approval for use in severe asthma is based on positive data from a separate phase III trial among Chinese patients.7,8 The results from the Chinese study reinforce existing data for mepolizumab in patients with severe asthma.8-13 Adverse events were consistent with the known safety profile for mepolizumab with no new emerging safety issues specific to Chinese patients.8-13 The global clinical development programme included four key clinical trials – DREAM9, MENSA10, SIRIUS11 and MUSCA.12 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.9-14
The 52-week phase III trial in Chinese patients with severe asthma studied the effect of mepolizumab relative to placebo, as add-on on the primary endpoint of reduction in the annual rate of clinically significant exacerbations (CSE).7,8 Patients in the trial who received mepolizumab compared to those who received placebo experienced 65% fewer CSE’s (0.45 vs.1.31 events/year, HR [95% CI]: 0.35 [0.24, 0.50] p<0.001), had a 70% reduction in the frequency of CSE per year requiring hospitalisation or Emergency Department (ED) visits (RR [95% CI] 0.30 [0.12,0.77]; p=0.012), and a significantly increased period of time before patients experienced the first CSE requiring hospitalisation or ED visits (3.4% vs. 12.6%; HR [95% CI]: 0.26 [0.10, 0.69]; p=0.007).8
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).15