Congratulations to Zydus Therapeutics on the US FDA granting Priority Review to their New Drug Application for saroglitazar for the treatment of Primary Biliary Cholangitis (PBC)!
Kris Kowdley, MD, AGAF, FAASLD, FACP, FACG — Velocity Principal Investigator and EPICS-III Study Investigator — was featured in the Zydus Therapeutics announcement highlighting the Phase 3 results of the EPICS-III trial. In the study, saroglitazar met its primary endpoint, with 56.7% of patients achieving biochemical response versus 9.8% on placebo — a clinically meaningful result for patients whose disease continues to progress on UDCA.
A huge congratulations to Zydus, Dr. Kowdley and his team at our Seattle site, the global research teams, and most importantly, the patients who participated in this important study. Your contribution brings this potential new therapy one step closer to those who need it most.
Read the full press release in BioSpace: https://www.biospace.com/press-releases/zydus-therapeutics-new-drug-application-nda-for-saroglitazar-to-treat-primary-biliary-cholangitis-pbc-granted-priority-review-by-the-us-fda
