The Clinical Impact of Seladelpar in PBC Care

EP: 1.Understanding Seladelpar as a Second-Line Treatment for PBC

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EP: 2.The Clinical Impact of Seladelpar in PBC Care

EP: 3.What Sets Seladelpar Apart From Other PBC Therapies

EP: 4.Insights from Long-Term ASSURE Data for Seladelpar

While the primary biliary cholangitis (PBC) treatment landscape has long been limited to just a handful of agents with limited efficacy, 2024 saw a major shift in PBC management with the addition of 2 new second-line therapies.

Seladelpar (Livdelzi), a proliferator-activated receptor (PPAR) delta agonist, was one of these recent additions to the PBC treatment armamentarium and was a major topic of discussion at The Liver Meeting 2024 from the American Association for the Study of Liver Diseases (AASLD) in San Diego, California.

Findings from a 2.5-year interim analysis of the ongoing open-label phase 3 ASSURE study were presented in a late-breaking abstract at the meeting and highlight seladelpar’s sustained efficacy and long-term safety for the treatment of PBC.

In this segment, which is part 2 of a 4-part series, experts Palak Trivedi, MD, PhD, and Eric Lawitz, MD, discuss the clinical impact of having seladelpar as a treatment option for patients with PBC.

Trivedi begins by highlighting the various benefits of seladelpar, which addresses both clinical outcomes—such as improved liver blood tests and enhanced transplant-free survival—and patient-centered concerns like pruritus, which significantly affects quality of life.

Lawitz goes on to emphasize the importance of seladelpar for patients who either do not adequately respond to or cannot tolerate UDCA. For this underserved group, he says seladelpar provides a much-needed option to improve liver function and potentially prevent disease progression.

Experts:

Palak Trivedi, MD, PhD: associate professor and honorary consultant hepatologist and clinical research director for industry engagement at the University of Birmingham

Eric Lawitz, MD: medical director of the Texas Liver Institute and a clinical professor of medicine at the University of Texas Health San Antonio

Relevant disclosures for Trivedi include Bristol Myers Squibb, Gilead, Intercept, CymbaBay, and others. Relevant disclosures for Lawitz include 89Bio, Boehringer Ingelheim, Merck, Novo Nordisk, Sagimet Biosciences, AstraZeneca, Bristol Myers-Squibb, Cymabay, Eli Lilly, Gilead Sciences, GlaxoSmithKline, Intercept, Ipsen, Madrigal, Novartis, Regeneron, Takeda, Terns, Viking Therapeutics, AbbVie, and others.

References

1. ^{Brooks A. FDA Grants Accelerated Approval to Seladelpar (Livdelzi) for Primary Biliary Cholangitis. HCPLive. August 14, 2024. Accessed December 4, 2024. https://www.hcplive.com/view/fda-grants-accelerated-approval-to-seladelpar-livdelzi-for-primary-biliary-cholangitis}
2. ^{Brooks A. Seladelpar (Livdelzi) Demonstrates Long-Term Benefit for Primary Biliary Cholangitis. HCPLive. November 15, 2024. Accessed December 4, 2024. https://www.hcplive.com/view/seladelpar-livdelzi-demonstrates-long-term-benefit-primary-biliary-cholangitis}