GSK’s Linerixibat accepted for priority review for cholestatic pruritus in patients with primary biliary cholangitis in China

GSK has recently announced that its NDA for the use of linerixibat for the treatment of cholestatic pruritus in patients with primary biliary cholangitis, a rare autoimmune liver disease, has been accepted for priority review by China’s National Medical Products Administration. Linerixibat is an investigational inhibitor of the ileal bile acid transporter, developed to reduce mediators of cholestatic pruritus – an internal and relentless itch.

In addition, GLISTEN met both primary and key secondary endpoints demonstrating a rapid, significant and sustained improvement in cholestatic pruritus and itch-related sleep interference versus placebo. The safety profile of linerixibat was consistent with previous studies and the mechanism of IBAT inhibition.

Note that Cholestatic pruritus in PBC is a serious and debilitating condition, with patients experiencing sleep disturbance and impaired quality of life and sometimes requiring liver transplant in the absence of liver failure. In China, approximately 280,000 people are affected by PBC, and cholestatic pruritus, for which there are few effective treatment options, is estimated to impact up to 89% of PBC patients during the course of their disease.

Linerixibat has been granted Orphan Drug Designation in the US, EU and Japan for the treatment of cholestatic pruritus in patients with PBC. Marketing applications for linerixibat are currently under Health Authority review in the US, EU, UK and Canada.

---

---

Related Topics and Keywords

cholestatic pruritus, GSK's Linerixibat, primary biliary cholangitis