FDA approves drug for primary biliary cholangitis

Natalia Elliot | August 15, 2024 | News story | Research and Development FDA Approval, FDA approva;, Hepatology, liver, primary biliary cholangitis 

Accelerated approval has been granted for Gilead Science’s Livdelzi (seladelpar) to treat primary biliary cholangitis (PBC) by the US Food and Drug Administration (FDA).

PBC is a rare and chronic inflammatory liver disease, primarily affecting women. The disease currently has no cure and can cause liver damage with the possibility of liver failure if left untreated.

Clinical and preclinical trial data for seladepar have shown evidence that the drug has the ability to regulate genes involved in vile acid synthesis, inflammation, lipid metabolism and transport, and fibrosis, leading to a reduction in alkaline phosphate (ALP). Data such as improvement in survival or prevention of liver decompensation events have not yet been demonstrated.

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CEO and chairman of Gilead Sciences, Daniel O’Day, commented: “People living with PBC have been waiting for treatment advancements for many years. We look forward to leveraging Gilead’s long-standing expertise in liver disease to bring this promising new treatment to all those who could benefit.”

Saledepar has also been accepted for review by the UK medicines and Health products Regulatory Industry (MHRA) and the European Medicines Agency (EMA).

Natalia Elliot

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