GSK’s linerixibat wins priority review in China for rare liver disease

GSK plc announced today that China's National Medical Products Administration has accepted its new drug application for linerixibat for priority review, marking a significant development in the treatment of cholestatic pruritus in patients with primary biliary cholangitis, a rare autoimmune liver disease. This priority review status accelerates the evaluation process, potentially bringing the treatment to Chinese patients more quickly if approved. Linerixibat is an ileal bile acid transporter inhibitor designed specifically to address the debilitating symptom of cholestatic pruritus, which causes severe itching in patients with primary biliary cholangitis (PBC). PBC is a chronic autoimmune disease characterized by the progressive destruction of small bile ducts in the liver, leading to bile buildup and liver damage. The condition predominantly affects women and often requires lifelong management. The priority designation from Chinese regulators reflects the unmet medical need for PBC patients who experience inadequate relief from existing treatments. Cholestatic pruritus can significantly impact quality of life, affecting sleep, daily functioning, and mental health. By accepting GSK's application for expedited review, Chinese authorities have recognized the potential value of linerixibat in addressing this critical aspect of patient care.