Livdelzi FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 15, 2024.
FDA Approved: Yes (First approved August 14, 2024)
Brand name: Livdelzi
Generic name: seladelpar
Dosage form: Capsules
Company: Gilead Sciences, Inc.
Treatment for: Primary Biliary Cholangitis
Livdelzi (seladelpar) is a selective peroxisome proliferator-activated receptor delta (PPARδ) agonist used for the treatment of primary biliary cholangitis.
- Livdelzi is indicated 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.
This indication is approved under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). - Primary biliary cholangitis PBC is a rare, chronic inflammatory liver disease characterized by cholestasis and the accumulation of toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts. Symptoms include pruritus 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 works in the treatment of PBC by regulating critical metabolic and liver disease pathways involved in bile acid synthesis, inflammation, fibrosis and lipid metabolism, storage, and transport.
- The accelerated approval of Livdelzi was based primarily on data from the pivotal placebo-controlled Phase 3 RESPONSE study in which 62% of participants taking Livdelzi achieved the primary endpoint of composite biochemical response at month 12, versus 20% of participants taking placebo. Treatment with Livdelzi led to normalization of ALP values in 25% of trial participants at month 12 compared to no change in any of the trial participants receiving placebo. Patients treated with Livdelzi also demonstrated a statistically significant reduction in pruritus compared with placebo.
- Livdelzi capsules are administered orally, once daily, with or without food.
- Warnings and precautions associated with Livdelzi include risk of fracture, liver test abnormalities, and use in patients with biliary obstruction.
- Common adverse reactions (reported in ≥5% and higher compared to placebo) include headache, abdominal pain, nausea, abdominal distension, and dizziness.
Development timeline for Livdelzi
Further information
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