Zydus reports regional efficacy data for PBC drug saroglitazar

The exploratory analysis, led by Dr. Raj Vuppalanchi of the Indiana University School of Medicine, compared outcomes between 28 U.S. patients and a composite non-U.S. group of 69 participants. Data showed a 60.7% treatment difference in composite biochemical response for the U.S. subgroup, compared to a 41.6% difference in the non-U.S. cohort. While both groups demonstrated clear benefits over placebo, the U.S. population showed a more pronounced reduction in alkaline phosphatase levels from baseline.

Despite these regional variations, the safety profile remained consistent, with adverse events balanced between the treatment and placebo arms. Common side effects included pruritus, headache, and urinary tract infections. Saroglitazar, a PPAR α/γ agonist, is currently under FDA review for patients with primary biliary cholangitis who show inadequate response or intolerance to ursodeoxycholic acid. Zydus Therapeutics expects to launch the product in the United States by March 2027, pending regulatory approval.