{"id":17392,"date":"2024-12-10T15:11:07","date_gmt":"2024-12-10T07:11:07","guid":{"rendered":"https:\/\/flcube.com\/?p=17392"},"modified":"2024-12-10T15:11:11","modified_gmt":"2024-12-10T07:11:11","slug":"gsks-nucala-receives-fda-review-for-copd-indication-based-on-matinee-study-data","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=17392","title":{"rendered":"GSK’s Nucala Receives FDA Review for COPD Indication Based on MATINEE Study Data"},"content":{"rendered":"\n

UK-based pharmaceutical giant GSK (NYSE: GSK<\/a>) has announced that the US Food and Drug Administration (FDA) has accepted for review data from the MATINEE study. The study seeks an indication approval for GSK’s Nucala (mepolizumab) as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) who exhibit an eosinophilic phenotype. The FDA is expected to make its decision by May 7, 2025.<\/p>\n\n\n\n

MATINEE Study Design and Results<\/strong>
The MATINEE study assessed the efficacy and safety of mepolizumab in 804 patients with COPD, characterized by type 2 inflammation and a blood eosinophil count. The study enrolled COPD patients with diverse clinical presentations, including those with emphysema-only, chronic bronchitis-only, or a combination of both, and particularly focused on hard-to-treat patients. The primary endpoint was achieved when mepolizumab was added to inhaled maintenance therapy, showing a statistically significant and clinically meaningful reduction in the annualized rate of moderate\/severe exacerbations compared to placebo over a treatment period of 52-104 weeks.<\/p>\n\n\n\n

Nucala’s Mechanism of Action and Existing Indications<\/strong>
Nucala, an interleukin-5 (IL-5) inhibitor, was first approved in the US in 2015 for the treatment of severe asthma with an eosinophilic phenotype. Since then, the drug has received additional indications for chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), and more, generating USD 2.2 billion in sales in 2023. The potential approval for COPD would further expand Nucala’s therapeutic applications.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

UK-based pharmaceutical giant GSK (NYSE: GSK) has announced that the US Food and Drug Administration…<\/p>\n","protected":false},"author":1,"featured_media":17393,"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-17392","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-gsk","tag-market-approval-filings","tag-nyse-gsk"],"yoast_head":"\nGSK's Nucala Receives FDA Review for COPD Indication Based on MATINEE Study Data - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"UK-based pharmaceutical giant GSK (NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has accepted for review data from the MATINEE study. 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