Nonalcoholic Steatohepatitis: Current Thinking From the Division of Hepatology and Nutrition at the Food and Drug Administration

Affiliations

¹ Center for Drug Evaluation and Research Office of New Drugs, Office of Inflammation and Immunity, Division of Hepatology and Nutrition, US Food and Drug Administration, Silver Spring, MD.

Frank A Anania et al. Hepatology. 2021 May.

. 2021 May;73(5):2023-2027.

doi: 10.1002/hep.31687.

¹ Center for Drug Evaluation and Research Office of New Drugs, Office of Inflammation and Immunity, Division of Hepatology and Nutrition, US Food and Drug Administration, Silver Spring, MD.

No abstract available

References

1. Rinella ME, Tacke F, Sanyal AJ, Anstee QM. Participants of the AASLD/EASL Workshop. Report on the AASLD/EASL Joint Workshop on Clinical Trial Endpoints in NAFLD. Hepatology 2019;70:1424-1436.
1. Applications for FDA approval to market a new drug. Published 2019. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?C.... Accessed September 10, 2020.
1. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Noncirrhotic nonalcoholic steatohepatitis with liver fibrosis: developing drugs for treatment draft guidance for industry. Published December 2018. https://www.fda.gov/media/119044/download. Accessed September 10, 2020.
1. Angulo P, Kleiner DE, Dam-Larsen S, Adams LA, Bjornsson ES, Charatcharoenwitthaya P, et al. Liver fibrosis, but no other histologic features, is associated with long-term outcomes of patients with nonalcoholic fatty liver disease. Gastroenterology 2015;149:389-397.
1. Brunt EM, Kleiner DE, Wilson LA, Sanyal AJ, Neuschwander-Tetri BA, Nonalcoholic Steatohepatitis Clinical Research Network. Improvements in histologic features and diagnosis associated with improvement in fibrosis in nonalcoholic steatohepatitis: results from the Nonalcoholic Steatohepatitis Clinical Research Network treatment trials. Hepatology 2019;70:522-531.