close
close
Insights from long-term ASSURE data for Seladelpar

While the treatment landscape for primary biliary cholangitis (PBC) has long been limited to just a handful of agents with limited efficacy, 2024 saw a major shift in PBC treatment with the introduction of two 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 key topic of discussion at the American Association for the Study of Liver Diseases (AASLD) 2024 Liver Meeting in San Diego, California.

Results from a 2.5-year interim analysis of the ongoing open-label phase 3 ASSURE trial were presented in a recent abstract at the meeting and underline the sustained efficacy and long-term safety of seladelpar in the treatment of PBC.

In this section, the final part of a four-part series, experts Palak Trivedi, MD, PhD, and Eric Lawitz, MD, discuss the long-term ASSURE data and what they add to our understanding of the safety and effectiveness of Seladelpar PBC.

Trivedi first emphasizes the importance of the long-term safety profile of seladelpar and notes the lack of new treatment-related adverse events or concerning safety signals. While acknowledging the inherent limitations of safety extension studies without matched control groups, he describes how the ASSURE data provide confidence in the drug’s sustained biochemical response and tolerability and also advocates for real-world studies to validate these results and determine whether Seladelpar improvement without transplantation results in survival over time beyond its biochemical markers.

Similar to Trivedi, Lawitz emphasizes the importance of long-term follow-up care for chronic therapies. He notes that the ASSURE data not only confirm the stability of seladelpar’s safety profile, but also demonstrate a potential increase in efficacy with prolonged treatment. He points out that the consistent durability and lack of unexpected toxicities give doctors more confidence in prescribing Seladelpar for longer use.

Experts:

Palak Trivedi, MD, PhD: Associate Professor and Honorary Consultant in Hepatology and Clinical Research Director for Industry Engagement at the University of Birmingham

Eric Lawitz, MD: Medical Director of the Texas Liver Institute and 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) shows long-term benefits in 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

Leave a Reply

Your email address will not be published. Required fields are marked *