GSK's Linerixibat Receives Priority Review in China for Rare Liver Disease-Related Pruritus
核心洞察
GSK announced that China's National Medical Products Administration has accepted linerixibat for priority review to treat cholestatic pruritus (搜索) in primary biliary cholangitis (搜索) patients.
The application is based on positive GLISTEN phase III trial data showing significant and sustained improvement in cholestatic pruritus (搜索) versus placebo.
Linerixibat targets an estimated 280,000 PBC patients in China, with up to 89% experiencing cholestatic pruritus (搜索) during their disease course.
GSK announced that China's National Medical Products Administration has accepted its new drug application for linerixibat for priority review, marking a significant regulatory milestone for the treatment of cholestatic pruritus (搜索) in patients with primary biliary cholangitis (搜索) (PBC). The investigational inhibitor of the ileal bile acid transporter (搜索) (IBAT) represents a potential breakthrough for managing the debilitating itch associated with this rare autoimmune liver disease.
GLISTEN Trial Success Drives Regulatory Submission
The priority review acceptance is based on positive data from the GLISTEN phase III trial, which was presented at the European Association for the Study of the Liver (EASL) Congress. The study met both primary and key secondary endpoints, demonstrating rapid, significant and sustained improvement in cholestatic pruritus (搜索) and itch-related sleep interference compared to placebo. The safety profile of linerixibat was consistent with previous studies and aligned with the expected mechanism of IBAT inhibition.
Addressing Significant Unmet Medical Need in China
Cholestatic pruritus (搜索) in PBC presents a serious clinical challenge, with patients experiencing sleep disturbance and impaired quality of life. In severe cases, patients may require liver transplant even in the absence of liver failure. In China, approximately 280,000 people are affected by PBC, and cholestatic pruritus is estimated to impact up to 89% of PBC patients during the course of their disease. Currently, there are few effective treatment options available for this condition.
Mechanism of Action and Global Development Strategy
Linerixibat functions as a targeted oral agent that inhibits bile acid re-uptake, thereby reducing multiple mediators of pruritus in circulation. This mechanism addresses the underlying pathophysiology of cholestatic pruritus (搜索) associated with PBC.
The drug has received Orphan Drug Designation in the United States, European Union and Japan for treating cholestatic pruritus (搜索) in PBC patients. Marketing applications are currently under review by health authorities in the US, EU, UK and Canada. Linerixibat is not yet approved anywhere in the world.
GSK's Expanding Hepatology Portfolio
The linerixibat development program represents part of GSK's broader strategy to extend its inflammation expertise into hepatology. The company is developing treatments for chronic and life-threatening fibro-inflammatory liver conditions, with a pipeline that includes potential therapies for chronic hepatitis B (搜索) and steatotic liver disease, including metabolic dysfunction-associated steatohepatitis (搜索) (MASH) and alcohol-associated liver disease (搜索) (ALD).