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Opportunities and challenges following approval of resmetirom for MASH liver disease

Nature Medicine (2024)Cite this article

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The US Food and Drug Administration (FDA) has approved the first drug, resmetirom, for metabolic dysfunction-associated steatohepatitis (MASH), but much work remains for the industry, practitioners and health systems so that this approval will benefit all patients.

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Fig. 1: Cascading effects of the approval of resmetirom.
Fig. 2: Challenges and actions in the implementation of resmetirom.

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Acknowledgements

J.V.L., D.I.W., H.E.M. and C.J.K. acknowledge support to ISGlobal from grant CEX2018-000806-S, funded by MCIN/AEI/10.13039/501100011033, and the ‘Generalitat de Catalunya,’ through the CERCA program, outside of the submitted work.

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Authors and Affiliations

  1. City University of New York Graduate School of Public Health and Health Policy (CUNY SPH), New York, NY, USA

    Jeffrey V. Lazarus & Nevin Cohen

  2. Barcelona Institute for Global Health (ISGlobal), Hospital Clínic, University of Barcelona, Barcelona, Spain

    Jeffrey V. Lazarus, Dana Ivancovsky Wajcman, Henry E. Mark & Christopher J. Kopka

  3. Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain

    Jeffrey V. Lazarus

  4. Global NASH Council, Washington, DC, USA

    Jeffrey V. Lazarus, Dana Ivancovsky Wajcman, Henry E. Mark, Zobair M. Younossi & Paul N. Brennan

  5. Beatty Liver and Obesity Research Program, Inova Health System, Falls Church, VA, USA

    Zobair M. Younossi

  6. Division of Liver Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA

    Meena B. Bansal

  7. Fatty Liver Alliance, Toronto, Ontario, Canada

    Michael Betel

  8. Division of Molecular and Clinical Medicine, University of Dundee, Dundee, UK

    Paul N. Brennan

Authors
  1. Jeffrey V. Lazarus
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  4. Zobair M. Younossi
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Correspondence to Jeffrey V. Lazarus.

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Competing interests

J.V.L. acknowledges grants to ISGlobal from AbbVie, Boehringer Ingelheim, Echosens, Gilead Sciences, Madrigal, MSD, Novo Nordisk, Pfizer and Roche Diagnostics; consulting fees from Echosens, NovoVax, GSK, Novo Nordisk and Pfizer; and payment or honoraria for lectures from AbbVie, Echosens, Gilead Sciences, Janssen, Moderna, MSD, Novo Nordisk and Pfizer, outside of the submitted work. Z.M.Y. acknowledges consulting fees from Intercept, Cymabay, Boehringer Ingelheim, Bristol Myers Squibb, GSK, NovoNordisk, AstraZeneca, Siemens, Madridgal, Merck, Ipsen and Abbott, outside of the submitted work. M.B.B. acknowledges grants or contracts to her institution from the NIH, the CDC/NIOSH, Pfizer, the Kinetix Group and Histoindex; consulting fees from Kinetix, Madrigal, Pfizer, Fibronostics, NOVO Nordisk, GSK and Merck; and payment or honoraria from Madrigal, NOVO Nordisk and GSK, outside of the submitted work. M.B. acknowledges grants to the Fatty Liver Alliance from Madrigal Pharmaceuticals, Inventiva, Regeneron, Hoffmann-La Roche, the Global Liver Institute, Siemens Healthineers, Aegle Medical, Pfizer, the Canadian Liver Foundation, Altimmune, KNS Canada, Sentrex Health Solutions, Novo Nordisk, Intercept Pharmaceuticals and the Canadian Institute of Health Research; consulting fees from Hoffmann-La Roche, Madrigal Pharmaceuticals and the Global Liver Institute; payment or honoraria from Inventiva and MCI (grant to the Fatty Liver Alliance); and support for attending meetings and/or travel from Regeneron, Arizona Liver Health and the Liver Forum, outside of the submitted work. P.N.B. acknowledges consulting fees from Resolution Therapeutics and payment or honoraria for lectures from Takeda, outside of the submitted work. D.I.W., H.E.M., C.J.K. and N.C. declare no competing interests.

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Lazarus, J.V., Ivancovsky Wajcman, D., Mark, H.E. et al. Opportunities and challenges following approval of resmetirom for MASH liver disease. Nat Med (2024). https://doi.org/10.1038/s41591-024-02958-z

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