What type of study is this?

This is a Literature Review study.

August 26, 2025

Non-Invasive Tests: Establishing efficacy for metabolic dysfunction associated steatohepatitis beyond the biopsy—current perspectives from the division of hepatology and nutrition, US Food and Drug Administration

Key Points

Non-invasive tests may replace liver histology as surrogate endpoints for metabolic dysfunction-related treatments, improving drug development efficiency.
The FDA acknowledges the need for evidence-based alternatives, as reliance on liver histology can delay patient access to new therapies.
Regulatory mechanisms allow data submission for non-invasive tests’ consideration as reasonable surrogate endpoints for metabolic dysfunction assessments.
Using non-invasive tests has the potential to align clinical outcomes with drug approval processes, thus providing timely therapies for MASH.

Abstract

To support drug development for metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis, multiple stakeholders including patients, clinicians, and investigators have communicated a desire to move away from liver histology. FDA accelerated approval is based on a surrogate endpoint (such as liver histology) that has less definitive evidence tying it to the clinical endpoint (such as death or liver transplant) but nonetheless is considered reasonably likely to predict clinical benefit -- a reasonably likely surrogate endpoint (RLSE). This communication is intended to provide some of the regulatory considerations on adopting non-invasive tests in lieu of liver histology as a RLSE in drug development for MASH. We will also describe FDA mechanisms and the methods by which data can be submitted to the FDA to consider proposals for NIT use in place of liver histology as RLSEs.

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Cite This Study

Anania et al. (Tue,) studied this question.

synapsesocial.com/papers/68af63ddad7bf08b1eae3e7d https://doi.org/https://doi.org/10.1097/hep.0000000000001509

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