A U.S. Food and Drug Administration advisory committee on Tuesday voted to support the benefit-risk profile of Zydus Lifesciences' saroglitazar magnesium for the treatment of primary biliary cholangitis (PBC), according to officials familiar with the panel's deliberations. The recommendation follows the FDA's granting of priority review status for the drug's New Drug Application, with a PDUFA target action date set for November 27, 2026.

Saroglitazar, a first-in-class dual PPAR-alpha/gamma agonist already approved in India for metabolic liver disease and diabetic dyslipidaemia, showed statistically significant reductions in alkaline phosphatase — a key biochemical marker of PBC progression — in the Phase 3 EPICS-III trial. Panellists acknowledged the unmet need in PBC, a rare autoimmune liver disease predominantly affecting middle-aged women, noting that existing approved therapies such as obeticholic acid leave a substantial proportion of patients without adequate disease control.

The advisory committee's endorsement is not binding on the FDA but carries significant weight in the agency's final determination. Several panellists cited the drug's favourable safety data and its dual mechanism of action as differentiating factors from current standard-of-care options, including ursodeoxycholic acid. Patient advocates testifying before the panel described the debilitating fatigue and itch associated with inadequately treated PBC, urging the committee to consider quality-of-life endpoints alongside biochemical outcomes.

Zydus Lifesciences, headquartered in Ahmedabad, India, called the committee's feedback an important milestone in its strategy to expand saroglitazar's global footprint. The company has been building its U.S. regulatory presence and views a successful PBC approval as a platform for further indications, including non-alcoholic steatohepatitis. Analysts at several investment firms noted that a positive advisory outcome materially improves the probability of FDA approval before year-end, potentially positioning saroglitazar as the first novel mechanism approved in PBC in several years.

The PBC therapeutics market has attracted growing attention from pharmaceutical developers given the rare disease designation pathways, orphan drug incentives, and a patient population with significant unmet need. Intercept Pharmaceuticals, whose obeticholic acid holds an accelerated approval in PBC, and Ipsen, which markets elafibranor under the brand name Iqirvo, are expected to face new competition should saroglitazar receive full FDA approval following the November review deadline.