Redefinition of Fatty Liver Disease from NAFLD to MAFLD through the Lens of Drug Development and Regulatory Science
Open Access
- 22 October 2021
- journal article
- review article
- Published by Xia & He Publishing in Journal of Clinical and Translational Hepatology
- Vol. 10 (2), 374-382
- https://doi.org/10.14218/jcth.2021.00408
Abstract
Metabolic (dysfunction)-associated fatty liver disease (MAFLD) affects a third of the population and is a leading cause of liver-related death. Since no effective treatments exist, novel approaches to drug development are required. Unfortunately, outdated terminology and definitions of the disease are hampering efforts to develop new drugs and treatments. An international consensus panel has put forth an influential proposal for the disease to be renamed from nonalcoholic fatty liver disease (NAFLD) to MAFLD, including a proposal for how the disease should be diagnosed. As allies with the many stakeholders in MAFLD care―including patients, patients’ advocates, clinicians, researchers, nurse and allied health groups, regional societies, and others―we are aware of the negative consequences of the NAFLD term and definition. We share the sense of urgency for change and will act in new ways to achieve our goals. Although there is much work to be done to overcome clinical inertia and reverse worrisome recent trends, the MAFLD initiative provides a firm foundation to build on. It provides a roadmap for moving forward toward more efficient care and affordable, sustainable drug and device innovation in MAFLD care. We hope it will bring promising new opportunities for a brighter future for MAFLD care and improve care and outcomes for patients of one of the globe’s largest and costliest public health burdens. From this viewpoint, we have revisited this initiative through the perspectives of drug development and regulatory science.Keywords
This publication has 81 references indexed in Scilit:
- Farnesoid X nuclear receptor ligand obeticholic acid for non-cirrhotic, non-alcoholic steatohepatitis (FLINT): a multicentre, randomised, placebo-controlled trialThe Lancet, 2015
- Low Awareness of Nonalcoholic Fatty Liver Disease Among Patients at High Metabolic RiskJournal of Clinical Gastroenterology, 2015
- Unsuccessful trial accrual and human subjects protections: An empirical analysis of recently closed trialsClinical Trials, 2014
- Clinical trials in the Middle East and North Africa (MENA) Region: Grandstanding or Grandeur?Contemporary Clinical Trials, 2013
- Heterogeneity of fibrosis patterns in non‐alcoholic fatty liver disease supports the presence of multiple fibrogenic pathwaysLiver International, 2013
- Childhood Obesity for Pediatric GastroenterologistsJournal of Pediatric Gastroenterology and Nutrition, 2013
- Nonalcoholic fatty liver disease (NAFLD): Is it really a serious condition?Journal of Hepatology, 2012
- Design and validation of a histological scoring system for nonalcoholic fatty liver diseaseJournal of Hepatology, 2005
- Nonalcoholic fatty liver disease in the pediatric populationClinics in Liver Disease, 2004
- Shifting SandsPhilosophical Topics, 2000