Gilead’s Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by FDA
Gilead Sciences, Inc. has received accelerated approval from the FDA for Livdelzi® (seladelpar) in the treatment of primary biliary cholangitis (PBC). Livdelzi can be used in combination with ursodeoxycholic acid (UDCA) for adults who have not responded adequately to UDCA or as a monotherapy for those who cannot tolerate UDCA. However, it is not recommended for individuals with decompensated cirrhosis.
The accelerated approval is supported by the pivotal Phase III RESPONSE study, where 62% of participants treated with Livdelzi met the primary endpoint of a composit...
