By VETTAPHARMA reporter – Derek Roche: GSK plc announced that its new drug application (NDA) for linerixibat — an investigational ileal bile acid transporter (IBAT) inhibitor — has been accepted for priority review by China’s National Medical Products Administration for the treatment of cholestatic pruritus in patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease.
The NDA submission is supported by positive data from the GLISTEN Phase III trial, which demonstrated rapid, significant and sustained improvement in cholestatic pruritus and itch-related sleep interference versus placebo, with a safety profile consistent with previous studies and the IBAT inhibition mechanism.
Cholestatic pruritus in PBC is described as a serious and debilitating condition, often causing sleep disturbance and impaired quality of life, and in some cases leading to liver transplant even without liver failure. In China, about 280,000 people are affected by PBC, and it is estimated that up to 89% of these patients experience cholestatic pruritus during the course of the disease.
Linerixibat has been granted Orphan Drug Designation in the United States, European Union, and Japan, and marketing applications are currently under review in the US, EU, UK, and Canada. However, linerixibat is not yet approved anywhere in the world.
In addition to its clinical evaluation, linerixibat works by inhibiting bile acid re-uptake, which reduces circulating mediators of pruritus associated with PBC.
