By VETTAPHARMA reporter – Derek Roche: Zydus Therapeutics reported that the U.S. Food and Drug Administration granted priority review to the New Drug Application for saroglitazar for the treatment of primary biliary cholangitis (PBC), a rare autoimmune liver disease affecting patients who have an inadequate response or intolerance to ursodeoxycholic acid (UDCA). The FDA assigned a Prescription Drug User Fee Act target action date of November 27, 2026.
The NDA is supported by results from the Phase IIb/III EPICS-III trial evaluating saroglitazar magnesium, a dual peroxisome proliferator-activated receptor (PPAR) alpha/gamma agonist, in adults with PBC. The study enrolled patients with inadequate response to UDCA or those unable to tolerate standard therapy.
Saroglitazar met the primary endpoint of biochemical response, with 56.7% of treated patients achieving response compared with 9.8% of patients receiving placebo. The study also demonstrated statistically significant improvements in alkaline phosphatase levels, a key biomarker used to assess disease activity and progression in PBC.
Primary biliary cholangitis is a chronic autoimmune condition characterized by progressive destruction of intrahepatic bile ducts, which can lead to fibrosis, cirrhosis, liver failure, and the need for liver transplantation. Despite availability of UDCA, a substantial proportion of patients continue to experience disease progression, creating demand for additional treatment options.
The regulatory milestone marks a significant step in Zydus’ strategy to expand its innovation-driven specialty portfolio beyond traditional generic and branded businesses. Saroglitazar has already received orphan drug and fast-track designations from the FDA, reflecting continued regulatory support for therapies targeting rare liver diseases with unmet medical needs.
For patients, approval could provide a new oral treatment option aimed at improving biochemical disease control and potentially slowing disease progression. Commercially, a successful approval would position Zydus within the growing PBC treatment market, where demand for second-line therapies continues to increase as diagnosis rates and disease awareness improve.
Quick FAQs
1. What is saroglitazar?
Saroglitazar is an investigational dual PPAR alpha/gamma agonist being developed for the treatment of primary biliary cholangitis.
2. What regulatory update did Zydus receive?
The FDA granted priority review to the saroglitazar NDA and assigned a target action date of November 27, 2026.
3. What is the study/trial?
EPICS-III is a Phase IIb/III clinical trial evaluating saroglitazar in patients with primary biliary cholangitis who had inadequate response or intolerance to UDCA.
4. What is the disease condition?
Primary biliary cholangitis is a chronic autoimmune liver disease that progressively damages bile ducts and can lead to cirrhosis and liver failure.
5. What were the key EPICS-III results?
Biochemical response was achieved in 56.7% of saroglitazar-treated patients compared with 9.8% of placebo-treated patients.
6. Why is the priority review important?
Priority review shortens FDA evaluation timelines and may accelerate patient access to new therapies addressing serious diseases with unmet medical need.
