Press release
Gilead’s Livdelzi® (Seladelpar) Demonstrated Consistent Efficacy and Safety Regardless of Prior Treatment History in New Data Presented at EASL 2025
– 60% of Participants with Prior Fibrate or Obeticholic Acid Treatment Achieve Biochemical Response with Livdelzi – – New Evidence Supports Livdelzi Delivers
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n– 60% of Participants with Prior Fibrate or Obeticholic Acid Treatment Achieve Biochemical Response with Livdelzi –\n\n– New Evidence Supports Livdelzi Delivers Clinically and Statistically Significant Improvements in Pruritus –\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nGilead Sciences, Inc. (Nasdaq: GILD) today announced new data from multiple analyses which reinforce that Livdelzi® (seladelpar), known as Lyvdelzi® in the European Union, is effective and generally well-tolerated for the treatment of primary biliary cholangitis (PBC) and also provides sustained biochemical response in adults with PBC regardless of prior treatment history. Another analysis provides evidence supporting that Livdelzi delivered clinically and statistically significant improvements in pruritus. These data and more were presented at the European Association for the Study of the Liver (EASL) Congress 2025 in Amsterdam, Netherlands, from May 7–10.\n\nLivdelzi Efficacy in Participants with Prior Fibrate or Obeticholic Acid Use\n\nAn interim analysis from ASSURE (NCT03301506), an ongoing, open-label, long-term study, reinforces the efficacy and safety profile of Livdelzi in people with PBC, including those with prior fibrate or obeticholic acid use. This analysis assesses participants from the pivotal Phase 3 placebo-controlled RESPONSE (NCT04620733) study and after participant rollover into the open-label ASSURE study, with or without prior fibrate or obeticholic acid use.\n\nAmong those with 18 months of exposure to Livdelzi, including 12 months in RESPONSE and 6 months in ASSURE, 60% (9/15) of participants with prior fibrate or obeticholic acid use achieved the composite biochemical response, as compared to 62% (54/87) of those without prior fibrate or obeticholic acid use. Among participants who started Livdelzi in ASSURE after previously receiving placebo in RESPONSE, 64% (7/11) of participants with prior fibrate or obeticholic acid use, as compared to 78% (32/41) of participants without prior fibrate or obeticholic acid use achieved the composite biochemical response after 6 months of receiving Livdelzi (Month 6 of ASSURE). Safety was similar regardless of prior fibrate or obeticholic acid use. No treatment-related serious adverse events (SAEs) were reported.\n\n“Building on the momentum of Livdelzi’s launch, these new data presented at EASL fur...