Zydus Therapeutics has cleared a key regulatory milestone in the United States, with the FDA granting Priority Review to its New Drug Application (NDA) for saroglitazar for the treatment of Primary Biliary Cholangitis (PBC), a rare, progressive liver disease.
The agency has set a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026, placing the therapy on an accelerated review timeline typically reserved for drugs that may offer meaningful improvements over existing treatment options.
The NDA is backed by late-stage evidence from the EPICS-III Phase 3 trial, which showed a strong biochemical response in patients with PBC who had an inadequate response to or intolerance of ursodeoxycholic acid (UDCA).
In the study, 56.7% of patients treated with saroglitazar achieved a biochemical response compared with 9.8% in the placebo group—a treatment difference of 48%.
The therapy also delivered significant improvements in key liver enzyme markers. Saroglitazar reduced mean alkaline phosphatase (ALP) levels by 33.5%, compared with a 6.5% increase in the placebo group, producing a treatment difference of 40.1%.
“The acceptance of our NDA with Priority Review highlights the significant unmet need that exists for patients with PBC and represents an important step in the path to making saroglitazar available in the US,” said Managing Director of Zydus Lifesciences, Sharvil Patel.
“We look forward to collaborating with the US FDA during the NDA Priority Review process and will, in parallel, continue to build our medical affairs and commercialization capabilities towards a potential US launch by March 2027.”
The EPICS-III study, a randomized, double-blind, placebo-controlled Phase 3 trial, enrolled 148 patients and met its primary endpoint at Week 52. It also showed statistically significant reductions in pruritus at Week 24, with saroglitazar improving itch scores compared with placebo.
“The magnitude of separation between saroglitazar and placebo in biochemical response is a clinically meaningful result for patients whose disease continues to progress on UDCA,” said Dr. Kris Kowdley, Director, Liver Institute Northwest.
"Achieving meaningful reductions in ALP is an important treatment goal in PBC as it is a surrogate marker predictive of long-term outcomes. These results suggest saroglitazar may provide a promising therapeutic option for patients with a suboptimal response to UDCA alone, when ALP continues to rise above target.”
Safety findings were broadly favorable. Serious adverse events occurred in 6.3% of patients receiving saroglitazar versus 11.1% in the placebo group, with none considered treatment-related.
If approved, Zydus Therapeutics plans to launch saroglitazar in the US by March 2027.
The company says the Priority Review designation underscores both regulatory confidence and the urgent need for new therapies in PBC, a condition that can progress to fibrosis, cirrhosis, liver transplant, or death.
