{"id":20887,"date":"2023-03-14T23:52:00","date_gmt":"2023-03-14T15:52:00","guid":{"rendered":"https:\/\/flcube.com\/?p=20887"},"modified":"2025-01-07T23:53:53","modified_gmt":"2025-01-07T15:53:53","slug":"gsks-nucala-gains-nmpa-approval-for-severe-eosinophilic-asthma-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=20887","title":{"rendered":"GSK’s Nucala Gains NMPA Approval for Severe Eosinophilic Asthma in China"},"content":{"rendered":"\n

UK-based GSK plc (NYSE: GSK<\/a>) has announced that a market approval filing for Nucala (mepolizumab) has been accepted by the National Medical Products Administration (NMPA) in China. The anti-interleukin-5 (IL-5) monoclonal antibody is seeking a second indication approval for use as an add-on maintenance treatment for severe eosinophilic asthma (SEA) in adults and adolescents.<\/p>\n\n\n\n

Understanding Severe Eosinophilic Asthma<\/strong>
SEA is a severe form of asthma characterized by high levels of white blood cells called eosinophils, which cause inflammation and swelling. This condition is linked to an increased risk of exacerbations requiring hospitalization or potentially fatal asthma attacks. Nucala\u2019s filing is supported by data from three Phase III global trials and a 52-week Phase III China study, which found no inconsistency between the drug\u2019s performance in Chinese and non-Chinese populations.<\/p>\n\n\n\n

Previous Approvals and Market Entry<\/strong>
First approved globally in 2015, GSK secured its initial approval in China for Nucala in November 2021, for use in adults with eosinophilic granulomatosis with polyangiitis (EGPA). The drug was added to the National Reimbursement Drug List (NRDL) for this indication in January 2023, enhancing its accessibility for patients.<\/p>\n\n\n\n

Significance of the Approval<\/strong>
The acceptance of the filing for a second indication underscores GSK’s commitment to expanding the therapeutic applications of Nucala in China. This development is expected to provide additional treatment options for patients suffering from severe eosinophilic asthma, improving their quality of life and reducing the risk of severe asthma attacks.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

UK-based GSK plc (NYSE: GSK) has announced that a market approval filing for Nucala (mepolizumab)…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[184,38,914],"class_list":["post-20887","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-gsk","tag-market-approval-filings","tag-nyse-gsk"],"yoast_head":"\nGSK's Nucala Gains NMPA Approval for Severe Eosinophilic Asthma in China - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"UK-based GSK plc (NYSE: GSK) has announced that a market approval filing for Nucala (mepolizumab) has been accepted by the National Medical Products Administration (NMPA) in China. 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