Zydus Therapeutics' Saroglitazar NDA for PBC gets US FDA Priority Review

Zydus Therapeutics, a subsidiary of Zydus Lifesciences, announced that the US FDA granted Priority Review to its New Drug Application (NDA) for saroglitazar to treat Primary Biliary Cholangitis (PBC). The FDA has set a PDUFA target action date of November 27, 2026. The NDA is supported by positive EPICS-III Phase 3 trial results, which demonstrated a significant biochemical response: 56.7% of patients treated with saroglitazar achieved the primary endpoint compared to 9.8% on placebo (a 48% treatment difference, p < 0.001). Saroglitazar also showed a 33.5% reduction in mean alkaline phosphatase (ALP) levels, versus a 6.5% increase in the placebo group. If approved, Zydus Therapeutics plans to launch saroglitazar in the United States in Q4 of FY27, addressing a significant unmet medical need for PBC patients.