Thirteenth World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease: selected highlights, Los Angeles, California, USA, 19–21 November 2015

Abstract

Dr Sanyal described how he and his colleagues have created a multiagency discussion group that brings together the Food and Drug Administration, the European Medicines Agency, and researchers to explore and clarify the regulatory process of drugs for nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) [1]. Dr Sanyal also discussed the farnesoid X nuclear receptor ligand obeticholic acid for non-cirrhotic NASH (FLINT) trial of obeticholic acid, which used a ‘vanguard’ design and early termination based on interim analyses of efficacy to minimize the need for liver biopsies [1]. A 72-month study on the use of obeticholic acid in NASH is currently in progress. According to Dr Sanyal, obeticholic acid ‘could be the first drug approved for severe NASH’. However, the FLINT trial revealed safety and tolerability issues such as elevations in low-density lipoprotein-cholesterol levels and pruritis, respectively. Of note, the noninvasive FIB4 score predicted therapeutic response in this trial http://www.hepa titisc.uw.edu/page/clinical-calculators/fib-4.