Redefinition of Fatty Liver Disease from NAFLD to MAFLD through the Lens of Drug Development and Regulatory Science
Year: 2021
Type: review
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 Unfortunately, outdated terminology and definitions of the disease are hampering efforts to develop new drugs and treatments.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.
Authors: Yasser Fouad, Melissa Palmer, Minjun Chen, Arie Regev, Rajarshi Banerjee, Rob Myers, Robert Riccio, Richard Torstenson, Ramy Younes, Puneet S. Arora, Henrik Landgren, Morten A. Karsdal, Martin Blake, David A. Shapiro, Hans-Juergen Gruss, Muhammad Y. Sheikh, Dina Attia, Steven Bollipo, Alastair D. Smith, Bradley Freilich, Robert G. Gish, Detlef Schuppan
Institutions: Minia University, Ascletis Pharma Inc. (China), National Center for Toxicological Research, United States Food and Drug Administration, Eli Lilly (United States), Perspectum Ltd. (United Kingdom), Gilead Sciences (United States), Syneos Health (United States), Allergan (United Kingdom), Boehringer Ingelheim (Germany), Genentech, AbbVie (United Kingdom), Nordic Bioscience (Denmark), Resonance Health (Australia), Beni-Suef University, John Hunter Hospital, University of Newcastle Australia, Kansas City Research Institute, Loma Linda University, Beth Israel Deaconess Medical Center, Harvard University, University Medical Center of the Johannes Gutenberg University Mainz
Language: English
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W3210478373