Zydus secures FDA priority review for Saroglitazar NDA in Primary Biliary Cholangitis

FDA sets November 27, 2026 PDUFA date as Phase 3 EPICS-III trial demonstrates significant biochemical response and favorable safety profile in PBC patients

The US Food and Drug Administration (FDA) has granted priority review to the New Drug Application (NDA) for saroglitazar, an investigational treatment for Primary Biliary Cholangitis (PBC) to Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Limited.

The NDA seeks approval of saroglitazar for use in combination with ursodeoxycholic acid (UDCA) in adult patients who have shown an inadequate response to UDCA, as well as a monotherapy option for patients unable to tolerate UDCA. 

The regulatory body has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026.

Priority Review status is reserved for therapies that, if approved, may offer significant improvements in the treatment, diagnosis, or prevention of serious conditions, enabling the FDA to allocate additional resources and accelerate the review process.

“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, Dr. 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 in the fourth quarter of FY 27,” added Dr. Patel.