– 60% of Participants with Prior Fibrate or Obeticholic Acid Treatment Achieve Biochemical Response with Livdelzi –
– New Evidence Supports Livdelzi Delivers Clinically and Statistically Significant Improvements in Pruritus –
Gilead 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.
Livdelzi Efficacy in Participants with Prior Fibrate or Obeticholic Acid Use
An 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.
Among 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.
“Building on the momentum of Livdelzi’s launch, these new data presented at EASL further reinforce its potential as a meaningful treatment option for people living with PBC,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “We are particularly encouraged by the sustained biochemical response seen with Livdelzi, even among those who previously received fibrates or obeticholic acid. These results strengthen the evidence supporting Livdelzi’s efficacy and tolerability across a broad population of patients, including those seeking alternatives to current therapies. We remain focused on addressing significant unmet needs and driving progress in liver health.”
Livdelzi and Meaningful Change in Pruritus
Up to 80% of people with PBC experience symptoms such as pruritus (chronic itch) and fatigue, both of which can profoundly compromise quality of life. The Pruritus Numeric Rating Scale (NRS) can evaluate treatment effects to see if a therapy is working, as well as examine the meaningful within-person change (MWPC) in the Pruritus NRS that people with PBC with pruritus perceive as a beneficial treatment effect. Using anchor-based analyses, a new study of the qualitative data from the participants of the RESPONSE trial with moderate-to-severe pruritus (NRS ≥ 4) at baseline (n=72) provides evidence supporting that Livdelzi delivered clinically and statistically significant improvements in pruritus.
Results demonstrated that MWPC estimates of ≥ 3-points on the Pruritus NRS corresponded to “moderate improvement” as validated by PGI-C and 1-category improvement for PGI-S anchors. The data overall, including half of those interviewed (n=6/12), suggest a 3-point improvement in Pruritus NRS, as seen with seladelpar in the RESPONSE study, is a meaningful change. These findings highlight the potential of Livdelzi to address this debilitating symptom.
NRS scores were measured against two anchor analyses, the 7-day recall Patient Global Impression of Severity of pruritus (PGI-S) and the Patient Global Impression of Change of pruritus (PGI-C), which were administered at study visits. The MWPC threshold estimates were validated using distribution-based methods and empirical cumulative distribution function (eCDF) curves. Additionally, previously collected qualitative interviews were used to evaluate meaningful change on the Pruritus NRS in people with PBC with pruritus (NRS≥ 4) outside of the trial.
“Seladelpar is uniquely positioned as the only once-daily oral treatment that has statistically significant outcomes for both the underlying disease and the burdensome symptom of pruritus in people with PBC,” said Alejandra Maria Villamil, MD, Chief of Autoimmune Liver Diseases Unit Hospital Italiano de Buenos Aires Buenos Aires, Argentina. “The demonstrated improvement in pruritus, combined with its established safety and efficacy profile, reinforces seladelpar as an on-label treatment option for people with PBC.”
Expanding Global Access for the Treatment of PBC in EEA
Recently, the European Commission (EC) granted conditional marketing authorization for Lyvdelzi (seladelpar) for the treatment of PBC in combination with UDCA in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. Lyvdelzi (an orphan designated product) provides an important treatment option for people living with the rare liver disease in the European Economic Area (EEA). Gilead is working with health authorities across Europe to ensure people living with PBC who are eligible for seladelpar have access as soon as possible. Lyvdelzi has been granted conditional marketing authorization in the EU. Continued approval of Lyvdelzi for the approved indication may be contingent on verification and description of clinical benefit in confirmatory trial(s).
Outside of the EEA, Livdelzi was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2024 and conditional approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in January 2025.
Regulatory review for Livdelzi is also underway in Canada and Australia.
For more information on the EASL Congress 2025 and Gilead’s presentations, please visit the congress website.
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