GlaxoSmithKline ("GSK") announced that NMPA has recently approved Nucala® (Mepolizumab injection) for the maintenance treatment of severe eosinophilic asthma (SEA) in adults and adolescents aged 12 years and above. Nucala® is the first targeted human anti-interleukin-5 (IL-5) monoclonal antibody biologic in China for this indication.

Asthma is a major health burden in China, where approximately 46 million adults suffer from asthma. About 6% of them have severe asthma, which can cause an increased risk of acute exacerbations requiring hospitalization and even potentially fatal asthma attacks. The daily lives of people with severe asthma are severely affected and treatment is costly. In China, 15.5% of people with asthma have experienced an exacerbation requiring hospitalization in the past 12 months.

The Guidelines for the Prevention and Management of Bronchial Asthma (2020 edition), developed by the Chinese Medical Association's Section of Respiratory Diseases, cites an unmet need for treatment of this disease in China. The guidelines specifically mention evidence for anti-IL-5 biologic therapies and Mepolizumab, noting that anti-IL-5 targeted therapies can reduce asthma exacerbations, emergency room or hospitalization rates, use of oral corticosteroids, and improve asthma control and lung function.

The approval was based on positive results from an independent Phase III clinical trial in Chinese patients, and the effectiveness of Mepolizumab in the Chinese population reinforces existing data in a broader population showing that Mepolizumab reduces exacerbations in patients with severe asthma. Adverse reactions were consistent with the known safety profile of Mepolizumab, with no new safety concerns for Chinese patients. The global clinical development program included four pivotal clinical trials - DREAM, MENSA, SIRIUS and MUSCA - which established the efficacy and safety profile. The safety data for Mepolizumab in severe eosinophilic asthma come from pivotal, long-term clinical studies and real-world research.

This 52-week Phase III trial in Chinese patients examined the efficacy of Mepolizumab as maintenance therapy in patients with severe eosinophilic asthma, with the primary endpoint being a clinically significant reduction in the rate of acute asthma exacerbations compared to the placebo group.

In 2021, China approved Mepolizumab injection for the treatment of adult patients with eosinophilic granulomatous polyangiitis (EGPA). This time, China approved the extension of its therapeutic scope for the maintenance treatment of severe eosinophilic asthma (SEA) in adults and adolescents aged 12 years and older. Epidemiologic, clinical and pathophysiologic studies have shown that patients with eosinophilic granulomatous polyangiitis (EGPA) usually also have asthma, which is often severe.

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