The CHMP has adopted a positive opinion recommending approval of Lynavoy for the treatment of cholestatic pruritus in adults with primary biliary cholangitis. Cholestatic pruritus is a common symptom in people living with primary biliary cholangitis, a rare autoimmune liver disease that can progress to cirrhosis, liver failure and the need for liver transplantation. GLISTEN met its primary and key secondary endpoints, showing rapid, significant and sustained improvements in cholestatic pruritus and itch‑related sleep interference compared with placebo. In primary biliary cholangitis, bile flow from the liver is disrupted and excess bile acids in circulation are thought to contribute to cholestatic pruritus. It can be debilitating, with patients experiencing sleep disturbance, fatigue and impaired quality of life.