Resmetirom is used in a specific liver-disease population. It should not be described as a general treatment for fatty liver disease.
U.S. indication
Current U.S. labeling for Rezdiffra identifies resmetirom, used together with diet and exercise, for adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis consistent with F2 to F3 fibrosis. The approval was granted under the accelerated approval pathway.
MASH terminology
The terms NASH and MASH refer to the same underlying inflammatory fatty-liver disease, with MASH being the newer terminology increasingly used by professional organizations. FDA labeling retains NASH terminology, while the EMA indication uses MASH.
European indication
The EMA authorized Rezdiffra in conjunction with diet and exercise for adults with noncirrhotic MASH and moderate to advanced fibrosis, F2 to F3. The EU authorization is conditional.
Cirrhosis
Current U.S. labeling states that Rezdiffra should be avoided in patients with decompensated cirrhosis. Resmetirom is not a general treatment for established advanced liver failure.
Treatment context
Resmetirom is intended to be used alongside lifestyle measures rather than replacing dietary and physical-activity interventions. The appropriate treatment plan depends on fibrosis stage, liver status, comorbidities and other clinical factors.
Investigational uses
Clinical studies continue to investigate resmetirom in additional populations, including well-compensated NASH cirrhosis. Such studies should not be presented as established indications.