GSK's cholestatic pruritus treatment Lynavoy gets US FDA approval

(Sharecast News) - GSK said on Thursday that the US Food and Drug Administration has approved its drug 'Lynavoy', or linerixibat, for the treatment of cholestatic pruritus in adults with primary biliary cholangitis, marking the first approved therapy in the US for the condition. The FTSE 100 pharmaceutical giant said Lynavoy, an ileal bile acid transporter inhibitor, targets the underlying drivers of chronic itch associated with the rare autoimmune liver disease, which affects up to 89% of patients and can significantly impair quality of life.

It said the approval was based on results from the phase three 'GLISTEN' trial, which met both primary and key secondary endpoints, demonstrating rapid improvements in itch as early as two weeks and sustained benefits over 24 weeks, alongside improvements in sleep disruption linked to the condition.

"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, head of respiratory, immunology and inflammation research and development at GSK.

He added that the approval represented "the first liver medicine from our pipeline to receive approval, underscoring our commitment to developing meaningful innovation across the spectrum of liver disease."

Cholestatic pruritus is described as an internal itch that cannot be relieved by scratching and can lead to fatigue, sleep disturbance and, in severe cases, the need for liver transplantation.

Existing treatment options were said to be limited.

GSK noted that regulatory reviews for linerixibat were ongoing in the European Union, UK, Canada and China.

The drug had also received orphan drug designation in the US, EU and Japan, and priority review status in China.

Separately, the company noted that it recently agreed to grant Alfasigma exclusive global rights to develop, manufacture and commercialise linerixibat, subject to regulatory approvals.

At 1223 GMT, shares in GSK were down 1.34% at 1,946.5p.

Reporting by Josh White for Sharecast.com.

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