Zydus Therapeutics has announced that the US Food and Drug Administration (FDA) granted Priority Review (PR) to the New Drug Application (NDA) for saroglitazar. The proposed indication is for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026.

PR directs FDA attention and resources to applications for drugs that, if approved, may provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.

Dr. Sharvil Patel, MD, Zydus Lifesciences, said, "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. 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 commercialisation capabilities towards a potential US launch by March 2027."

The NDA is supported by the EPICS-III trial phase 3 results, a randomised, double-blind, placebo-controlled study evaluating saroglitazar in adult patients with PBC who had an inadequate response to, or intolerance of UDCA. The EPICS-III trial phase 3 results will be presented as a late-breaking session at the European Association for the Study of the Liver (EASL) Congress in Barcelona, Spain on Saturday, May 30, 2026.

Raj Vuppalanchi, MD, Professor of Medicine, Indiana University School of Medicine and Global Principal Investigator for the EPICS-III study, said, "EPICS-III is a registrational study that tested saroglitazar as a second-line treatment in patients with PBC. The study met its primary endpoint, demonstrating a clinically meaningful biochemical response, along with a favorable safety and tolerability profile."

Saroglitazar was generally well-tolerated in the EPICS-III trial. Most Treatment-Emergent Adverse Events (TEAEs) were mild to moderate in nature. Serious adverse events were reported in 6.3 percent of patients in the saroglitazar group versus 11.1 percent in the placebo group. None were considered related to study treatment by the investigators, and there were no treatment-related deaths. TEAEs occurring in >5 percent of patients and at least 2 percent more frequently on saroglitazar versus placebo were headache, hypertension, upper respiratory tract infection, abdominal pain, COVID-19, diarrhea, and vitamin D deficiency.