Expert Panel Review to Compare FDA and EMA Guidance on Drug Development and Endpoints in Nonalcoholic Steatohepatitis

Abstract

Nonalcoholic steatohepatitis (NASH) has become a focus for drug development owing to its increasing prevalence and health care burden. The global prevalence of NASH is estimated to range from 1.5% to 6.5%,1 with a higher prevalence of 12% to 14% among middle-aged US populations.2,3 The increasing prevalence of nonalcoholic fatty liver disease (NAFLD) further exacerbates the evolving shortages of livers for transplantation by negatively affecting the pool of suitable donors.4,5 This issue and the rising burden of end-stage liver disease due to NASH and NASH-related hepatocellular carcinoma (HCC) are major public health concerns.