FDA approves treatment for primary biliary cholangitis

FDA has approved 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.  PBC is a rare autoimmune disease in which the small bile ducts in the liver become injured and inflamed and without treatment are eventually destroyed. Most patients are females who are diagnosed with PBC between 40 and 60 years of age; without treatment they experience a slow progression of liver disease to cirrhosis, liver failure, and potential need for liver transplantation or death. The recommended dosage is 10 mg orally once daily. The most common adverse reactions reported with use of Livdelzi are headache, abdominal pain, nausea, abdominal distension, and dizziness. Use of Livdelzi is not recommended in patients who have or who develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). Providers should measure patients’ baseline liver tests before prescribing Livdelzi and monitor these tests during treatment. Providers should also be mindful of potential side effects of bone fractures. See full prescribing information for additional information on risks associated with Livdelzi.