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GSK wins FDA approval for first drug treating liver disease itch

March 19, 2026 8:22 AM

The U.S. Food and Drug Administration approved GSK's (NYSE: GSK) drug Lynavoy for treating severe itching caused by primary biliary cholangitis, marking the first treatment approved for this condition.

The drug targets cholestatic pruritus, or severe itch, in patients with primary biliary cholangitis (PBC). Existing therapies do not directly address this symptom, according to the company's Thursday announcement.

"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 GSK executive Kaivan Khavandi.

Primary biliary cholangitis is a chronic autoimmune disease where the body's immune system attacks and destroys small bile ducts in the liver. The condition affects more than 100,000 adults in the United States, according to National Institutes of Health data.

The information is based on a GSK press release statement.

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