葛兰素史克:Nucala在中国获批用于嗜酸性粒细胞表型的严重哮喘治疗 |
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GSK plc (GSK,GSK.L) said that the China National Medical Products Administration has approved Nucala or 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.The approval was based on a separate Phase III trial among Chinese patients, reinforcing the efficacy and safety data of mepolizumab.This is the second indication for mepolizumab in China, with approval for use in adults with eosinophilic granulomatosis with polyangiitis or EGPA received in 2021. 葛兰素史克股份有限公司(GSK,GSK.L)表示,中国国家医药管理局已批准Nucala或mepolizumab作为12岁及以上成人和青少年严重嗜酸性粒细胞哮喘的附加维持治疗。Nucala是中国第一个被批准用于成人和青少年患者的抗白细胞介素-5(IL-5)靶向治疗。该批准基于中国患者的单独III期试验,加强了mepolizumab的疗效和安全性数据。这是mepolizumab在中国的第二个适应症,批准用于2021年接受的嗜酸性肉芽肿伴多血管炎或EGPA的成人。 Epidemiological, clinical and pathophysiological studies show that patients with EGPA usually also have asthma, which is often severe.. 流行病学,临床和病理生理学研究表明,EGPA患者通常也患有哮喘,这通常是严重的。。 Asthma is a major health burden in China affecting an estimated 46 million adults. In China, 15.5% of people with asthma have experienced an exacerbation requiring a hospital visit in the preceding 12 months. 哮喘是中国的主要健康负担,估计影响4600万成年人。在中国,15.5%的哮喘患者在过去12个月内经历了需要住院治疗的恶化。 |
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