GSK plc has received approval from the US Food and Drug Administration for Lynavoy (linerixibat), marking the first approved treatment in the United States for cholestatic pruritus in adult patients with Primary Biliary Cholangitis.

Lynavoy is an ileal bile acid transporter (IBAT) inhibitor that works by reducing the accumulation of bile acids, a key driver of chronic itch associated with PBC. The condition affects up to 89 percent of patients with the rare autoimmune liver disease and is often debilitating, significantly impacting sleep, daily functioning and overall quality of life.

The approval is based on results from the Phase III GLISTEN trial, a global, randomised, placebo-controlled study that met both primary and key secondary endpoints. The data demonstrated rapid improvements in itch as early as two weeks, with sustained benefits over 24 weeks, along with reduced sleep disturbance related to itching.

Linerixibat showed a safety profile consistent with previous studies, with the most commonly reported adverse events being mild to moderate diarrhoea and abdominal pain. 

The approval represents a major milestone in addressing a long-standing unmet need in PBC care, where treatment options for chronic itch have historically been limited.

Separately, GSK has entered into a licensing agreement with Alfasigma S.p.A., under which the company will acquire global exclusive rights to develop, manufacture and commercialise linerixibat. The transaction is currently pending regulatory approvals.

Lynavoy has received orphan drug designation in the United States, European Union and Japan, reflecting its importance in treating rare diseases. Regulatory filings for the therapy are also under review in multiple global markets, including Europe, the UK, Canada and China.

The approval underscores GSK’s continued focus on advancing treatments for chronic liver diseases, leveraging its expertise in inflammation and immunology to address complex conditions such as hepatitis B and metabolic liver disorders.