Panelists discuss how the main treatment goals for patients with primary biliary cholangitis (PBC) include improving liver biochemistry, preventing disease progression to cirrhosis, managing symptoms, and enhancing overall quality of life through regular monitoring and appropriate therapeutic interventions.

A predictive tool that incorporates several blood biomarkers may help to identify primary biliary cholangitis (PBC) patients who are less likely to respond to treatment with ursodeoxycholic acid, known as UDCA, during the early stages of the disease, a study has found.

In recognition of the US Food and Drug Administration accelerated approval of Gilead’s seladelpar (Livdelzi) and other recent evolutions in primary biliary cholangitis (PBC), the latest HCPLive Special Report spotlights a conversation between a trio of subject matter experts on the latest advancements in PBC and their implications for disease management.

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the Phase 2b TRANSFORM trial met its primary endpoint, showing statistically significant improvement in ALP (Alkaline Phosphatase) for both doses tested versus placebo. The trial evaluated setanaxib, a NOX enzyme inhibitor, in patients with primary biliary cholangitis (PBC) and elevated liver stiffness.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi® (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The use of Livdelzi is not recommended for people who have or develop decompensated cirrhosis.

On June 28, 2024 the Committee for Medicinal Products for Human Use (CHMP), issued an opinion to the European Commission to revoke the marketing authorization for OCALIVA in Europe.