{"id":656,"date":"2024-08-15T20:59:47","date_gmt":"2024-08-15T12:59:47","guid":{"rendered":"https:\/\/flcube.com\/?p=656"},"modified":"2024-10-13T21:09:37","modified_gmt":"2024-10-13T13:09:37","slug":"gilead-secures-fda-accelerated-approval-for-livdelzi-in-liver-disease-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=656","title":{"rendered":"Gilead Secures FDA Accelerated Approval for Livdelzi in Liver Disease Treatment"},"content":{"rendered":"\n<p>Gilead Sciences Inc. (NASDAQ: GILD) has received accelerated approval from the U.S. FDA for its liver disease treatment, Livdelzi (seladelpar), following its acquisition of CymaBay Therapeutics Inc. for $4.3 billion earlier this year.<\/p>\n\n\n\n<p>The FDA has authorized Livdelzi for use in combination with ursodeoxycholic acid (UDCA) to treat primary biliary cholangitis (PBC) in adults who have not adequately responded to UDCA, or as a monotherapy for those who are intolerant to UDCA. However, the drug is not recommended for patients with decompensated cirrhosis.<\/p>\n\n\n\n<p>Livdelzi enters a competitive PBC market alongside Ipsen\u2019s Iqirvo (elafibranor), which received approval in June and is being co-developed with GENFIT (Nasdaq and Euronext: GNFT).<\/p>\n\n\n\n<p>The FDA\u2019s decision was based on results from the Phase III RESPONSE study, which demonstrated that 62% of participants receiving Livdelzi achieved the primary endpoint of composite biochemical response at 12 months, compared to just 20% in the placebo group. Additionally, 25% of those on Livdelzi returned to normal alkaline phosphatase (ALP) levels, a key cholestatic marker, versus 0% in the placebo cohort. It is important to note, however, that the accelerated approval was granted on the basis of ALP reduction; improvements in survival or the prevention of liver decompensation events have yet to be established, necessitating post-approval confirmatory trials.<\/p>\n\n\n\n<p>In a related move, Gilead recently paid $320 million to Johnson &amp; Johnson\u2019s subsidiary, Janssen, to acquire the latter\u2019s royalty rights on global sales of seladelpar, which had previously entitled Janssen to an 8% royalty under a prior agreement with CymaBay.- <a href=\"https:\/\/flcube.com\">Flcube.com<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Gilead Sciences Inc. (NASDAQ: GILD) has received accelerated approval from the U.S. FDA for its&#8230;<\/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":[226,1025],"class_list":["post-656","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-gilead-sciences","tag-nasdaq-gild"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Gilead Secures FDA Accelerated Approval for Livdelzi in Liver Disease Treatment - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Gilead Sciences Inc. 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