Finally! Something FDA-Approvable for Non-alcoholic Steatohepatitis (NASH)?

Authors:
Scott S. Malinowski, PharmD

Reviewers:
Joshua Neumiller, PharmD
Abigail M. Klutts, PharmD, BCACP

Citation:
Francque SM, Bedossa P, Ratziu V, et al.  A randomized, controlled trial of the pan-PPAR agonist lanifibranor in NASH.  N Engl J Med 2021; 385:1547-1558

The Problem

Nonalcoholic steatohepatitis (NASH) is quickly emerging as one of the most common reasons for both liver cirrhosis and liver transplant in the United States – soon predicted to overtake hepatitis C virus as the predominant etiology.^1,2 NASH is the advanced form of nonalcoholic fatty liver disease (NAFLD).  It is estimated that more than 25% of the world’s adult population has some degree of NAFLD, the vast majority of which is undiagnosed and asymptomatic.³ Currently, there are no FDA-approved medications to treat these disorders.

Given the etiological connection between the metabolic syndrome and NAFLD, and the fact that the disorder is typically identified during clinic visits for other medical problems, understanding risk factors, and treatment options is critical.