Posted by Michael Wonder on 14 Aug 2024
Gilead’s Livdelzi (seladelpar) granted accelerated approval for primary biliary cholangitis by US FDA
14 August 2024 - First and only treatment to demonstrate statistically significant reductions across key biomarkers, ALP normalisation and pruritus versus placebo.
Gilead Sciences today announced that the US FDA has granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
