LIVDELZI (Gilead Sciences Pty Ltd)
Product name
LIVDELZI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
190 (255 working days)
Active ingredients
seladelpar lysine
Registration type
NCE/NBE
Indication
LIVDELZI is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.