The US FDA approved linerixibat, branded as Lynavoy, on March 17, 2026, for cholestatic pruritus in primary biliary cholangitis (PBC) patients, ahead of the March 24 PDUFA date.23
Alfasigma acquired global rights to linerixibat from GSK in a deal worth up to $690M, including $300M upfront and $100M on FDA approval.13
Lynavoy is the first targeted treatment for cholestatic pruritus in PBC, showing significant itch reduction in the Phase III GLISTEN trial.13
PBC affects over 100,000 US adults; Lynavoy inhibits bile acid reuptake and has orphan drug designation.12
Alfasigma, which owns Ocaliva for PBC, plans launches; filings pending in EU, UK, China, Canada.3
GSK will receive additional milestones and royalties; approval triggers $100M payment to GSK.13
Sources:
1. https://www.pharmaceutical-technology.com/news/gsk-sells-liver-disease-drug-candidate-to-alfasigma-for-690m/
2. https://pharma.economictimes.indiatimes.com/amp/news/drug-approvals-and-launches/us-fda-approves-gsks-drug-for-liver-disease-related-itching/129690612
3. https://pharmaphorum.com/news/alfasigma-claims-early-fda-nod-ex-gsk-liver-drug