Evicenter
P&T meetings

Saroglitazar

Primary biliary cholangitis

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

Product information and disease descriptionPlace of product in therapyDisease descriptionBurden of Primary biliary cholangitis

Humanistic burden and health-related quality of life

4 evidence topics · 5 sources

ITCH-E study: full journal publication

“The MSP group reported significantly greater activity impairment due to PBC (57%) than the NMP group (36%; p < 0.001).” (opens the source at this quote in a new tab)

Pruritus and work productivity

“a positive association between pruritus severity and work hours lost among employed adults with PBC” (opens the source at this quote in a new tab)

TARGET-PBC: pruritus and treatment patterns

“Patients reporting clinically significant pruritus were more likely to receive treatment, but 33% had never received treatment” (opens the source at this quote in a new tab)

Validation of pruritus and patient-reported outcome instruments

“Convergent, discriminant, and known-groups validity were confirmed for all three NRS items and the PBC-40.” (opens the source at this quote in a new tab)