GlaxoSmithKline (GSK.US)'s new oral targeted drug “linexibat tablets” is to be included in priority review in China

The Zhitong Finance App learned that on July 4, the official website of the China Drug Administration Drug Evaluation Center (CDE) announced that linesibat tablets declared by GlaxoSmithKline (GSK.US) will be included in the priority review and are suitable for treating cholestatic itching in adult patients with primary biliary cholangitis (PBC). According to public information, this is linerixibat, an ileo-bile acid transport protein (IBAT) inhibitor currently being developed by GSK. The new drug application (NDA) for this product was accepted by the US FDA and the European Medicines Agency (EMA) in June of this year. The indication is to treat cholestatic pruritus in adult patients with primary biliary cholangitis (PBC).

As a cholestatic liver disease, PBC causes an obstruction of bile flow in the liver. The resulting excess circulating bile acid is thought to be the causative agent of cholestatic pruritus (an endogenous itch that cannot be relieved by scratching). This pruritus can occur at any stage of PBC disease or biochemical control, and varies in severity; approximately 90% of PBC patients experience this symptom. Although first-line PBC treatment can control the condition of about 70% of patients, it cannot reduce the severity or effects of pruritus. Cholestatic pruritus is a serious condition that can be disabling. Patients may experience sleep disorders, fatigue, decreased quality of life, and may even require a liver transplant without liver failure.

Linerixibat is an IBAT oral inhibitor that has the potential to treat cholestatic pruritus associated with PBC. By inhibiting bile acid reabsorption, linerixibat reduces various itchy media in circulation