Join us to hear PBC experts present the LIVDELZI clinical data on Wednesday, September 4, 2024, at 7 PM ET and 9 PM ET.

13 days 12 hours 25 minutes

Lower is better with LIVDELZI

LIVDELZI is the first and only primary biliary cholangitis (PBC) treatment that achieved statistically significant reduction across biochemical response, alkaline phosphatase (ALP) normalization, and pruritus vs placebo.1

  • 62% of patients achieved the composite biochemical response at month 121

  • 1 in 4 patients treated with LIVDELZI normalized their ALP at month 121

  • Rapid improvement in pruritus seen as early as month 1, with a statistically significant difference at month 6; improvements were observed through month 121,2

Discover Our Data

Biochemical response was defined as achieving ALP <1.67 x upper limit of normal (ULN), decrease in ALP of ≥15% from baseline, and total bilirubin (TB) ≤ULN.1

INDICATION AND USAGE

LIVDELZI is indicated for the treatment of primary biliary cholangitis (PBC), 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.

This indication is approved under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Limitation of use: Use of LIVDELZI is not recommended in patients who have or develop decompensated cirrhosis (eg, ascites, variceal bleeding, hepatic encephalopathy).

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References: 1LIVDELZI [prescribing information]. Foster City, CA: Gilead Sciences, Inc.; 2024. 2Hirschfield GM, Bowlus CL, Mayo MJ, et al. A phase 3 trial of seladelpar in primary biliary cholangitis. N Engl J Med. 2024;390(9):783-794. doi:10.1056/NEJMoa2312100