FDA Approves GSK’s Lynavoy as First Treatment for PBC-Related Itch

GSK plc has received approval from the U.S. Food and Drug Administration (FDA) for Lynavoy (linerixibat) for the treatment of cholestatic pruritus in adults with primary biliary cholangitis (PBC). The oral therapy is the first medicine approved in the United States specifically for this indication, addressing a major unmet need in patients with this rare autoimmune liver disease.

Lynavoy is an ileal bile acid transporter (IBAT) inhibitor designed to reduce the accumulation of bile acids that contribute to the severe itching experienced by many people with PBC. Cholestatic pruritus affects up to 89% of patients with PBC and can significantly impair quality of life, causing sleep disruption, fatigue, and in some cases contributing to consideration of liver transplantation even in patients without overt liver failure.

The FDA approval is supported by results from the global Phase III GLISTEN trial (NCT04950127), which demonstrated rapid and sustained improvements in itch severity and itch‑related sleep interference compared with placebo. Patients treated with linerixibat showed significant reductions in worst‑itch numerical rating score as early as week 2, with benefits maintained through 24 weeks of treatment. In the study, linerixibat significantly improved the monthly itch score compared with placebo (least‑squares mean difference: −0.72; p=0.001). Improvements were also observed in itch‑related sleep interference (p=0.024).

The safety profile of linerixibat was consistent with earlier studies and its mechanism of action. The most common adverse events were diarrhoea (61%) and abdominal pain (18%), which were mostly mild to moderate. Treatment discontinuation due to diarrhoea occurred in 4% of patients, compared with less than 1% in the placebo group.

“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,” said Kaivan Khavandi, SVP, R&D Head Respiratory, Immunology & Inflammation and Head of GSK Translational & Development Sciences at GSK. “For many patients, cholestatic pruritus remains a persistent and poorly addressed condition.”​

Clinical experts have also highlighted the importance of the approval. Christopher Bowlus, MD, Chief of Gastroenterology and Hepatology at the University of California, Davis, has noted that uncontrolled itching in PBC patients can be profound and difficult to manage, making the availability of a targeted therapy an important milestone in care.​

Linerixibat has received Orphan Drug Designation in the United States, European Union, and Japan, and has also been granted priority review in China, for the treatment of cholestatic pruritus in patients with PBC. Regulatory submissions are currently under review in the EU, UK, Canada, and China.

Earlier this month, GSK announced a licensing agreement with Alfasigma S.p.A. under which the Italian company will acquire worldwide exclusive rights to develop, manufacture, and commercialise linerixibat. The transaction remains subject to regulatory clearances, including review under the Hart‑Scott‑Rodino Act in the United States.​

The approval also marks a key milestone in GSK’s emerging hepatology pipeline, as the company expands its research efforts in conditions such as chronic hepatitis B, metabolic dysfunction‑associated steatohepatitis (MASH), and alcohol‑associated liver disease (ALD).

References

Lynavoy (linerixibat) approved by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis (PBC), 19 March 2026, Lynavoy (linerixibat) approved by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis (PBC) | GSK

Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN), ClinicalTrials.gov ID NCT04950127, https://clinicaltrials.gov/study/NCT04950127