{"id":27570,"date":"2025-02-21T13:16:22","date_gmt":"2025-02-21T05:16:22","guid":{"rendered":"https:\/\/flcube.com\/?p=27570"},"modified":"2025-02-21T13:16:24","modified_gmt":"2025-02-21T05:16:24","slug":"gileads-livdelzi-receives-conditional-ec-approval-for-primary-biliary-cholangitis","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=27570","title":{"rendered":"Gilead’s Livdelzi Receives Conditional EC Approval for Primary Biliary Cholangitis"},"content":{"rendered":"\n

US-based Gilead Sciences Inc. (NASDAQ: GILD<\/a>) announced that it has received conditional approval from the European Commission (EC) for its liver disease drug Livdelzi (seladelpar). The drug is approved for use in combination with ursodeoxycholic acid (UDCA) to treat primary biliary cholangitis (PBC) in adults who have an inadequate response to UDCA, or as monotherapy for those unable to tolerate UDCA.<\/p>\n\n\n\n

Drug Profile<\/strong>
Seladelpar, a PPAR-delta agonist, was acquired by Gilead in February 2023 through its USD 4.3 billion acquisition of CymaBay Therapeutics Inc.. In August 2024, Gilead paid USD 320 million to Johnson & Johnson’s subsidiary Janssen to acquire the rights to charge an 8% royalty on global sales of seladelpar.<\/p>\n\n\n\n

Regulatory Milestones<\/strong>
The drug was fast-tracked for marketing in the US in August 2024 and received approval in January 2025. It is currently awaiting regulatory decisions in Canada and Australia.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

US-based Gilead Sciences Inc. 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(NASDAQ: GILD) announced that it has received conditional approval from the European Commission (EC) for its liver disease drug Livdelzi (seladelpar). The drug is approved for use in combination with ursodeoxycholic acid (UDCA) to treat primary biliary cholangitis (PBC) in adults who have an inadequate response to UDCA, or as monotherapy for those unable to tolerate UDCA.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=27570\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Gilead's Livdelzi Receives Conditional EC Approval for Primary Biliary Cholangitis\" \/>\n<meta property=\"og:description\" content=\"US-based Gilead Sciences Inc. (NASDAQ: GILD) announced that it has received conditional approval from the European Commission (EC) for its liver disease drug Livdelzi (seladelpar). The drug is approved for use in combination with ursodeoxycholic acid (UDCA) to treat primary biliary cholangitis (PBC) in adults who have an inadequate response to UDCA, or as monotherapy for those unable to tolerate UDCA.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=27570\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China's Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-02-21T05:16:22+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-02-21T05:16:24+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/02\/2105-png.avif\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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