What medicine is Livdelzi (Seladelpar)?

Livdelzi (Seladelpar) is a selective peroxisome proliferator-activated receptor delta (PPARδ) agonist for the treatment of primary cholangitis; it is mainly suitable for use in combination with ursodeoxycholic acid (UDCA) to treat adult primary cholangitis (PBC) with poor response to UDCA, or for the treatment of patients who cannot tolerate UDCA. This indication was granted accelerated approval based on alkaline phosphatase (ALP) reduction. Improved survival or prevention of hepatic decompensation events have not been demonstrated.

Primary biliary cholangitisPBC is a rare, chronic inflammatory liver disease characterized by the accumulation of cholestasis and toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts. Symptoms include itching and fatigue, which can be debilitating. Progression of PBC is associated with an increased risk of liver-related mortality. Livdelzi is a PPARδ agonist that treats PBC by modulating key metabolic and hepatic pathways involved in bile acid synthesis, inflammation, fibrosis and lipid metabolism, storage and transport.

Livdelzi capsules are administered orally once daily with or without food. Livdelzi's accelerated approval was based primarily on data from the pivotal placebo-controlled Phase 3 response study, in which 62% of participants taking Livdelzi met the primary endpoint of composite biochemical response at month 12. At 12 months, Livdelzi treatment resulted in normalization of ALP values u200bu200bin 25% of trial participants, compared with no change in ALP values u200bu200bin any trial participant who received placebo. Patients treated with Livdelzi also showed a statistically significant reduction in pruritus compared to placebo.