TGA tick sets up PBAC win

Posted 2 February 2026 AM 

The TGA has approved Gilead’s oral primary biliary cholangitis (PBC) treatment Livdelzi after a year-long review, setting the drug up for a PBAC recommendation.

Livdelzi was accepted for review by the TGA in January 2025 and deferred by the PBAC in July, with the committee noting it “was of a mind to recommend seladelpar [Livdelzi], pending advice from the Therapeutic Goods Administration Delegate”. The PBAC revealed on Friday that it has recommended Livdelzi.