Nucala approved for use in China

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Biopharmaceutical company GSK announced its Nucala (mepolizumab) drug has been approved for use in China. Nucala is the first targeted anti-Interleukin-5 (IL-5) biologic available in China as an add-on maintenance treatment for severe eosinophilic asthma. 

Millions of people living in China are affected by severe asthma. The approval was given for use in adults and adolescents aged 12 years and older and based on a separate phase III trial among Chinese patients reinforcing mepolizumab’s efficacy and safety data.

According to the Chinese Thoracic Society 2020 Guidelines for Bronchial Asthma Prevention and Management, there is a growing and unmet need to treat this condition.  The guidelines also pinpoint evidence for targeted biologic therapy that could reduce asthma exacerbations, emergency or hospitalization, oral corticosteroid use and improve asthma control and lung function.

The separate, 52-week phase III trial data of Chinese patients reinforces existing data for mepolizumab in patients with severe asthma. According to the results, adverse events were consistent with the known safety profile for mepolizumab with no new emerging safety issues specific to Chinese patients.

Patients in the trial who received mepolizumab compared to those who received placebo experienced 65% fewer CSE’s events per year, a 70% reduction in the frequency of CSE per year requiring hospitalization or emergency department (ED) visits and a significantly increased period before patients experienced the first CSE requiring hospitalization or ED visits.

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