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 primary endpoint is to measure the change in liver stiffness measurement performed by transient elastography from Baseline to Week 52
Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA)
Incidences of Non-alcoholic Fatty Liver Disease (NAFLD) have been rising exponentially worldwide and are associated with co-morbidities including obesity, diabetes, hypertension and metabolic disorders
Earlier, the USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for PBC
Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients
Aman holds a bachelor’s degree in economics from Boston University and an MBA from Columbia University, New York
The company is also looking at an inorganic opportunity over the next two years to have a commercially ready footprint in the US
China has the highest number of clinical trials that were initiated in NAFLD in the APAC region over the past decade.
Saroglitazar Mg is an investigational compound in the USA/EU, undergoing Phase 2b/3 clinical trials in patients with Primary Biliary Cholangitis and Phase 2b in patients with Non- alcoholic Steatohepatitis
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