The FDA has approved linerixibat (Lynavoy) as the first drug to treat cholestatic pruritus (itching) caused by primary biliary cholangitis (PBC)[1]. PBC is a rare autoimmune disease of the liver that affects the biliary tract and is characterized by persistent itching, which occurs in up to 90% of patients[1]. Linerixibat is an oral medication that works as an inhibitor of the bile acid transporter (IBAT) and reduces the reabsorption of bile acids, thereby addressing the underlying cause of pruritus[2]. The approval is based on the positive results of the GLISTEN Phase III clinical trial, which demonstrated significant and sustained improvement in pruritus and sleep disturbances caused by pruritus compared to placebo[1]. Pruritus associated with PBC is a debilitating symptom that severely affects patients' quality of life, sleep, and mental health, and current PBC medications do not effectively treat this pruritus[1][4]. Linerixibat received orphan drug designation from both the FDA and the European Medicines Agency and is currently in the regulatory process in other countries, including the European Union, China and Canada[5].