The FDA has approved Livdelzi (seladelpar) for the treatment of primary biliary cholangitis. The drug is approved for use in adults who have an inadequate response to, or cannot tolerate, ursodeoxycholic acid, either in combination with it or as monotherapy.

Primary biliary cholangitis (PBC) is a rare, progressive autoimmune disease characterized by the inflammation and destruction of the small bile ducts within the liver. Without appropriate treatment, the disease can lead to cirrhosis, liver failure, and potentially necessitate liver transplantation. The condition predominantly affects women aged 40 to 60 years.

The recommended dosage of seladelpar is 10 mg orally once daily. Common adverse reactions include headache, abdominal pain, nausea, abdominal distension, and dizziness. Seladelpar is contraindicated in patients with decompensated cirrhosis, such as those with ascites, variceal bleeding, or hepatic encephalopathy. Baseline liver function tests should be obtained prior to initiating seladelpar, and patients should be monitored regularly for potential liver function abnormalities during treatment. Additionally, providers should be aware of the potential risk of bone fractures associated with the drug.

Seladelpar received accelerated approval based on surrogate endpoints, and the manufacturer is required to conduct post-marketing studies to confirm its clinical benefits. The drug also holds orphan drug designation and breakthrough therapy designation for the treatment of PBC.

For detailed prescribing information, including a complete list of risks and monitoring guidelines, refer to the full prescribing information.