Zydus Lifesciences Limited, through its wholly owned subsidiary Zydus Therapeutics, said the US FDA granted Priority Review to the New Drug Application for saroglitazar for the treatment of Primary Biliary Cholangitis. The US FDA assigned a PDUFA target action date of November 27, 2026.
The NDA is supported by the EPICS-III Phase 3 trial, which enrolled 148 patients with PBC who had an inadequate response to or intolerance of ursodeoxycholic acid. Saroglitazar met the primary endpoint of biochemical response at Week 52, with 56.7% of treated patients achieving biochemical response versus 9.8% on placebo, a treatment difference of 48%. Among participants with baseline ALP ≤ 3 times the upper limit of normal, biochemical response was 83.1% and 14.7%, respectively.
Saroglitazar showed a 40.1% treatment difference in mean alkaline phosphatase levels, reducing ALP by 33.5% versus a 6.5% increase on placebo. At Week 24, patients treated with saroglitazar also reported a statistically significant reduction in pruritus compared to placebo, with a change in 5-D Itch Total score of -5.9 versus -2.7.
Saroglitazar was generally well-tolerated, with serious adverse events reported in 6.3% of patients in the treatment group versus 11.1% in the placebo group. The EPICS-III results will be presented as a late-breaking session at the EASL Congress in Barcelona on May 30, 2026.
If approved, Zydus Therapeutics plans to launch saroglitazar in the United States in the fourth quarter of fiscal year 2027. Saroglitazar has received Orphan Drug Designation, Fast Track Designation and Priority Review from the US FDA for the treatment of PBC, which is a rare autoimmune disease that can lead to liver fibrosis, cirrhosis, or death.
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