Primary biliary cholangitis (PBC), is a rare, progressive autoimmune disease which gradually destroys the bile ducts, resulting in an accumulation of bile in the liver which can result in fibrosis, cirrhosis, the need for liver transplantation or death.

PBC disproportionately affects women, with 1 in 1,000 women over the age of 40 being afflicted, 9 times the rate for men.1 PBC is characterized by increases in biochemical markers, especially alkaline phosphatase (ALP), bilirubin and liver transaminases. Clinical symptoms include pruritus (itching) and fatigue, both of which can be severe.

PBC is a life-long condition. Medications can be used to manage and slow its progression.

We are currently conducting a late-stage clinical program with saroglitazar to assess efficacy and safety in patients with PBC who are uncontrolled on usual first line treatment.

REFERENCE: 1. Primary biliary cholangitis (2020) NORD (National Organization for Rare Disorders). Available at: https://rarediseases.org/rare-diseases/primary-biliary-cholangitis (Accessed: November 29, 2022). 2. Lazarus JZ, et al. Advancing the global public health agenda for NAFLD: a consensus statement. Nat Rev Gastroenterol Hepatol. 2022 Jan;19(1):60-78.