GSK's Lynavoy Approved for Cholestatic Pruritus in PBC Patients

On March 19, 2026, the U.S. Food and Drug Administration (FDA) approved GSK's drug Lynavoy for the treatment of severe itching associated with primary biliary cholangitis (PBC). This marks a significant advancement as Lynavoy is the first medication approved in the U.S. specifically targeting cholestatic pruritus in PBC patients. PBC is a chronic liver disease characterized by the immune system's attack on bile ducts, affecting over 100,000 adults in the United States, according to the National Institutes of Health.

GSK hails US FDA approval of Lynavoy for cholestatic pruritis formReuters

Lynavoy, also known as linerixibat, functions as an ileal bile acid transporter inhibitor, blocking a protein in the intestine that reabsorbs bile acids responsible for severe itching. In a late-stage clinical trial, the twice-daily oral medication demonstrated a statistically significant reduction in itch severity and related sleep disruption over a 24-week period compared to a placebo. This approval provides a much-needed treatment option for the approximately 89% of PBC patients who experience debilitating itch, which has been inadequately addressed by existing therapies.

Reuters

Primary biliary cholangitis leads to symptoms such as bone and joint aches, extreme fatigue, and severe itching. Current treatments for PBC-related pruritus primarily involve off-label medications, including Gilead's Livdelzi and Ipsen's Iqirvo, which do not specifically target the itching symptom. Mirum Pharmaceuticals is also developing a drug, volixibat, aimed at treating pruritus in PBC.

ReutersGSK hails US FDA approval of Lynavoy for cholestatic pruritis form

GSK's executive Kaivan Khavandi emphasized the importance of Lynavoy, stating, "The approval of Lynavoy in the US gives patients a much needed treatment option that offers rapid, significant and sustained improvement in the debilitating effects of itch caused by PBC." He noted that for many patients, cholestatic pruritus remains a persistent and poorly addressed condition. GSK is also pursuing regulatory reviews for Lynavoy in the European Union, United Kingdom, Canada, and China.

GSK hails US FDA approval of Lynavoy for cholestatic pruritis form

Despite the positive reception of Lynavoy's approval, GSK's shares fell by 1.3% to 1,947.00 pence on the day of the announcement, indicating some investor skepticism regarding the drug's market potential or pricing strategy. The company has not yet disclosed details about the pricing and availability of Lynavoy.

GSK hails US FDA approval of Lynavoy for cholestatic pruritis form

As GSK moves forward with the commercialization of Lynavoy, further developments in regulatory approvals across other regions are anticipated. The company aims to address the significant unmet need for effective treatments for cholestatic pruritus in PBC patients globally.

GSK hails US FDA approval of Lynavoy for cholestatic pruritis form