The CHMP has adopted a positive opinion recommending approval of Lynavoy for the treatment of cholestatic pruritus in adults with primary biliary cholangitis. A final decision from the European Commission is expected in the coming months.
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. It is associated with sleep disturbance, fatigue and impaired quality of life.
The recommendation is based on data from the GLISTEN phase 3 study. 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. The safety profile of linerixibat was consistent with previous studies and the mechanism of IBAT inhibition.
Francesco Balestrieri, CEO of Alfasigma, commented: “The CHMP’s positive opinion for linerixibat is an important milestone for people living with primary biliary cholangitis who experience cholestatic pruritus, a debilitating symptom that can significantly impact quality of life.”
He added: “This recommendation brings us one step closer to making a new treatment option available to appropriate patients, subject to regulatory approval and local access pathways, while supporting Alfasigma’s strategy to grow its rare and specialty care business focused on complex healthcare challenges in gastroenterology and immunology.”
In primary biliary cholangitis, bile flow from the liver is disrupted and excess bile acids in circulation are thought to contribute to cholestatic pruritus. The condition can occur at any stage of disease or biochemical control. It can be debilitating, with patients experiencing sleep disturbance, fatigue and impaired quality of life.
Data from the US indicate that itch is frequently undocumented in medical records and many patients with clinically significant symptoms do not receive treatment.
