02:36 PM EDT, 08/14/2024 (MT Newswires) -- Gilead Sciences ( GILD ) said Wednesday it has received accelerated approval from the US Food and Drug Administration for Livdelzi in combination with ursodeoxycholic acid to treat adult patients with primary biliary cholangitis who have an inadequate response for ursodeoxycholic acid.

Primary biliary cholangitis is a liver disease that damages the bile ducts.

The approval also allows for the use of Livdelzi, or seladelpar, as monotherapy in patients unable to tolerate ursodeoxycholic acid, the drugmaker said.

The approval is based on results from a placebo-controlled phase 3 Response trial that showed Livdelzi led to the normalization of alkaline phosphatase values, a marker that predicts risk for liver transplant and death, the company added.

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