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# Accelerated Approval for Gilead’s Livdelzi
- URL: https://www.fdaweb.com/accelerated-approval-for-gileads-livdelzi/
- Published: 2024-08-14T12:00:00.000Z
- Updated: 2026-09-14T14:38:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157572

FDA has granted accelerated approval to Gilead’s Livdelzi (seladelpar) to treat primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. A company [statement](https://www.gilead.com/news-and-press/press-room/press-releases/2024/8/gileads-livdelzi-seladelpar-granted-accelerated-approval-for-primary-biliary-cholangitis-by-us-fda?ref=fdaweb.com) says the approval was based primarily on data from the Phase 3 RESPONSE study. In the study, 62% of participants taking Livdelzi achieved the primary endpoint of composite biochemical response at month 12 versus 20% of participants taking a placebo.

Livdelzi is described as an oral PPAR-delta agonist for the treatment of primary biliary cholangitis. The company says PPAR-delta has been shown to regulate critical metabolic and liver disease pathways.