首页|Redefinition of Fatty Liver Disease from NAFLD to MAFLD through the Lens of Drug Development and Regulatory Science

Redefinition of Fatty Liver Disease from NAFLD to MAFLD through the Lens of Drug Development and Regulatory Science

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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 Unfortunately, outdated terminology and definitions of the disease are hampering efforts to develop new drugs and treatments.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, includ-ing 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 for-ward 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.

NAFLDMAFLDNASHFatty liver diseaseLiverFibrosis

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

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Department of Gastroenterology,Hepatology,and Endemic Medicine,Faculty of Medicine,Minia University,Minia,Egypt

Gan-nex/Ascletis Pharma Co Ltd,Beijing,China

Liver Consulting LLC,New York,NY,USA

Division of Bioinformatics and Biostatis-tics,National Center for Toxicological Research,US Food and Drug Administration,Jefferson,AR,USA

Eli Lilly and Company,Indianapolis,IN,USA

Perspectum Diagnostics Ltd,Oxford,UK

Gilead Sciences Inc,Foster City,CA,USA

Syneos Health LLC,Morrisville,NC,USA

Allergan Marlow International,Buckinghamshire,UK,AstraZeneca,Cambridge,UK

Boehringer Ingel-heim International,GmbH,Ingelheim,Germany

Genentech,Inc,South San Francisco,CA,USA

AbbVie,Marlow,Buck-inghamshire,UK

Nordic Bioscience A/S,Herlev,Denmark

Resonance Health,Burswood,WA,Australia

Intercept Phar-maceuticals Inc,San Diego,CA,USA

Fresno Clinical Research Center,Fresno,CA,USA

Gastroenterology and Hepatology Department,Beni-Suef University,Beni Suef,Egypt

Department of Gastroenterology and Endoscopy,John Hunter Hospital,Newcastle,NSW,Australia

School of Medicine and Public Health,University of Newcastle,Newcastle,NSW,Australia

Kan-sas City Research Institute,Kansas City,MO,USA

Division of Gastroenterology and Hepatology,Loma Linda University,Loma Linda,CA,USA

Institute of Translational Immunology and Research Center for Immune Therapy,University Medical Center,Mainz,Germany

Division of Gastroenterology,Beth Israel Deaconess Medical Center,Harvard Medical School,Boston,MA,USA

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2022

10.14218/JCTH.2021.00408

临床与转化肝病杂志(英文版)

临床与转化肝病杂志(英文版)

ISSN：
年,卷(期)：2022.10(2)
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