Global Liver Institute

What You Need to Know about Patient Advocacy & the First US Approval of a NASH Therapy


What You Need to Know about Patient Advocacy & the First US Approval of a NASH Therapy

What is RezdiffraPatient Prescribing Info 

Highlights of Prescribing Information – For Healthcare Providers

What to Know

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What is nonalcoholic steatohepatitis (NASH)?

NASH is an advanced stage of fatty liver disease. NASH is a serious, chronic, and progressive condition triggered by excessive liver fat accumulation, leading to inflammation and potentially resulting in fibrosis, liver scarring, and, in severe cases, cirrhosis, cancer, or liver failure. It’s also known as MASH (metabolic dysfunction-associated steatohepatitis).

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What is the news?

On Thursday, March 14, the U.S. Food and Drug Administration approved the first medication, Rezdiffra™ (resmetirom), developed by Madrigal Pharmaceuticals to treat the serious liver disease known as NASH.

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What does it do?

Rezdiffra™ is a once daily oral, liver-directed thyroid hormone receptor (THR) β-selective agonist designed to treat underlying causes of NASH in the liver, while improving multiple atherogenic lipid profiles.


Who is eligible?

Adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) to be used in conjunction with diet and exercise.


How will this impact patients?

With the first medication approved to treat NASH in the US, physicians can identify the eligible F2 and F3 patients within their practice or system to treat and start reversing this serious condition. This could save patients from progressing to cirrhosis, liver failure, or cancer and needing liver transplantation.


What’s next for GLI?

Pioneering NASH Patient Solutions: GLI’s Impact

  • GLI’s NASH Council was launched in 2017
    • 90 NASH Council Members, including organizations in the pharmaceutical industry, academic research, diabetes, obesity, patient advocacy, and more.
  • In 2019, GLI participated in the refinement of the ICD-10 code for NASH. The proposed changes included introducing specific codes for early (K74.01 – F1 or F2) and advanced (K74.02 – F3) hepatic fibrosis, to be coded with NASH. 
    • ICD-10 code K75. 81 for NASH is a medical classification as listed by WHO.
    • NAFLD is 76.0
  • GLI began hosting International NASH Day in 2019. In 2023, there were:
    • 100 Partners 
    • 55 Countries 
    • 31 Endorsing Organizations
  • GLI’s Beyond the Biopsy™ collaborative, launched in 2020, is dedicated to accelerating the acceptance and adoption of noninvasive diagnostics as an alternative to liver biopsy.
  • To establish clarity and precision of language around the disease, GLI and its NASH Council introduced The Language of NASH in August 2020, serving as a foundational communication tool to address the significant impact of the condition.
  • GLI and its NASH Council released the U.S. NASH Action Plan in December 2020 to define a comprehensive path forward to address NASH and its impact on patients and families in the US.
    • In December 2021, GLI established the NASH Scorecard to monitor the implementation of recommendations outlined in the NASH Action Plan. This year-end assessment highlights achievements across various stakeholder groups and serves as a crucial tool for the field to address remaining gaps and challenges.
  • GLI held an Externally-Led Patient-Focused Drug Development Meeting on NASH with the FDA in November 2021 to share the patient perspective on upcoming NASH drugs with regulators. To learn about themes, please view the report on the FDA website.
  • In June 2023, EASL and AASLD jointly announced new nomenclature guidelines for fatty liver disease. Steatotic liver disease was chosen as the overarching term, with the term metabolic dysfunction-associated steatotic liver disease (MASLD) replacing NAFLD and the term metabolic dysfunction-associated steatohepatitis (MASH) replacing NASH.

Nomenclature Shift

The naming conventions for certain liver conditions have recently undergone revisions.


FLD – Fatty Liver Disease

NAFLD – Nonalcoholic Fatty Liver Disease

NASH – Nonalcoholic Steatohepatitis


SLD – Steatotic Liver Disease

  1. MASLD – Metabolic Dysfunction-Associated Liver Disease
  2. MetALD – MASLD + Increased alcohol consumption (MetALD)

MASH – Metabolic Dysfunction-Associated Liver Steatohepatitis

The integration of these new terminologies into clinical practice and research requires a period of transition, as the use of old and new terms may coexist during this phase. Medical professionals, researchers, and patient advocacy organizations, like GLI, are anticipated to coordinate the implementation of these changes, ensuring that patients are informed and educated about the implications of the updated nomenclature for their individual conditions. Clear communication and dissemination of information are essential to facilitate a seamless understanding of these modifications within the medical community and among patients.

You may see GLI use NASH/MASH and NAFLD/MASLD during this transition period to help our audience become familiarized with the terminology. Be aware that search engines are not currently optimized to search for new terms, and keep in mind that it is important to include old as well as new terminology as resources and clinical research are transitioning.