Evicenter
P&T meetings

Saroglitazar

Primary biliary cholangitis

Manufacturer
Zydus Therapeutics
Regulatory submission
NDA submitted by May 2026
Last updated
81 sources

Executive summary

Burden of Primary biliary cholangitis

1 evidence topic · 3 sources

Summary

The adjusted U.S. prevalence of PBC in 2021 was 40.9 per 100,000 adults, corresponding to an estimated 105,506 adults. In the ITCH-E study, activity impairment was 57% in the moderate-to-severe pruritus group versus 36% in the no or mild pruritus group. A separate observational analysis reported one-year adjusted healthcare costs of $39,949 with pruritus versus $25,695 in controls. These observational comparisons describe disease burden rather than treatment effects.