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In 2024, 2025, the FDA added two approved agents, specifically Iqirvo (elafibranor, Ipsen/Genfit) and Livdelzi (seladelpar, Gilead), which got accelerated approvement for adults with ursodeoxycholic acid, that's for Iqirvo. Livdelzi was also found to improve pruritus in trials.
Moreover, there are other drugs, such as OCA, Ocaliva (obeticholic acid), that remains under its accelerated approval with label restrictions, ongoing scrutiny, confirmatory efficacy, questions. And so this has still not been really solidified in the patient population, but it seems to be accelerated and there seems to be work on it.
And there seems to be increased adoption of not just new treatments, but also of scoring of these patients, specifically GLOBE and UK-PBC scores, which helps earlier identification of non-responders to use with the ursodeoxycholic acid and timely add-on or switching to second-line agents. There have been symptom-first algorithms for cholestatic pruritus that are being formalized, anticipating IBAT availability.
Ahmad Anouti, MD, a pediatric resident at UT Southwestern Medical Center, spoke about the current treatment landscape for primary biliary cholangitis.In addition, he noted there has been an increased use of scoring to help identify patients who will not respond to ursodeoxycholic acid, the first-line therapy for PBC. With these scoring tools, physicians may determine early on if patients with PBC need to add on or switch to second-line therapy.
