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NASH field celebrates ‘hurrah moment’ with a first FDA drug approval for the liver disease

Madrigal’s resmetirom has scored a landmark FDA win, bolstering hopes for a diverse pipeline of drugs for non-alcoholic steatohepatitis.
  1. Katie Kingwell
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The non-alcoholic steatohepatitis (NASH) drug development landscape has long been a graveyard of failed programmes. The FDA’s approval of Madrigal’s resmetirom (Rezdiffra), an oral thyroid hormone receptor-beta (THRβ) agonist, now changes things for this potentially fatal liver disease.

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Nature Reviews Drug Discovery 23, 235-237 (2024)

doi: https://doi.org/10.1038/d41573-024-00051-1

Updates & Corrections

  • Update 19 March 2024: The article has been updated to note that the FDA's accelerated approval of resmetirom did not include a requirement for biopsy diagnosis in the prescribing information and to clarify that the phase III trial designed to provide confirmatory evidence to support full approval is ongoing. The status of the phase III trial of pegozafermin has been clarified, and a phase II trial of the combination of ervogastat and clesacostat has been added to the table.

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