Zydus Therapeutics'' New Drug Application (NDA) for Saroglitazar to treat Primary Biliary Cholangitis (PBC) granted Priority Review by the US FDA.
ZYDUSLIFE · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
Zydus Therapeutics, a wholly-owned subsidiary of Zydus Lifesciences, announced that the US FDA granted Priority Review to its New Drug Application for saroglitazar to treat Primary Biliary Cholangitis (PBC). The Phase 3 EPICS-III trial met its primary endpoint, with 56.7% of patients achieving biochemical response versus 9.8% on placebo (p < 0.001). The drug also reduced alkaline phosphatase levels by 33.5% compared to a 6.5% increase in the placebo group. The FDA has assigned a PDUFA target action date of November 27, 2026. If approved, Zydus plans to launch saroglitazar in the US in Q4 FY27. The drug already holds Orphan Drug Designation and Fast Track Designation from the FDA.
This Priority Review status represents a significant regulatory milestone and positive step toward US market entry for saroglitazar, which could become a treatment option for PBC patients who do not respond to standard therapy. A successful approval would expand Zydus Lifesciences' portfolio into the rare disease space in the US market.