{"id":35904,"date":"2025-06-24T22:53:08","date_gmt":"2025-06-24T14:53:08","guid":{"rendered":"https:\/\/flcube.com\/?p=35904"},"modified":"2025-06-24T22:53:08","modified_gmt":"2025-06-24T14:53:08","slug":"gsks-linerixibat-accepted-for-ema-review-for-cholestatic-pruritus-in-pbc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=35904","title":{"rendered":"GSK’s Linerixibat Accepted for EMA Review for Cholestatic Pruritus in PBC"},"content":{"rendered":"\n

UK-based GlaxoSmithKline (GSK; NYSE: GSK<\/a>) announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for linerixibat, an ileal bile acid transporter (IBAT) inhibitor. The application seeks approval for the treatment of cholestatic pruritus in patients with primary biliary cholangitis (PBC).<\/p>\n\n\n\n

Clinical Trial Results<\/strong>
The MAA submission is supported by positive outcomes from the Phase III GLISTEN study, which met its primary and key secondary endpoints. Linerixibat demonstrated rapid, significant, and sustained efficacy in reducing the severity of cholestatic pruritus and pruritus-related sleep disturbances compared to placebo.<\/p>\n\n\n\n

Global Regulatory Review<\/strong>
Linerixibat is also under review by the U.S. Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), highlighting GSK’s commitment to addressing unmet medical needs in PBC.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced that the European Medicines Agency (EMA) has accepted the…<\/p>\n","protected":false},"author":1,"featured_media":35907,"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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[278,184,38,914],"class_list":["post-35904","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-glaxosmithkline","tag-gsk","tag-market-approval-filings","tag-nyse-gsk"],"yoast_head":"\nGSK's Linerixibat Accepted for EMA Review for Cholestatic Pruritus in PBC - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for linerixibat, an ileal bile acid transporter (IBAT) inhibitor. 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