FDA Approves Injection Therapy for Metabolic-Associated Steatohepatitis in Adults with Moderate to Advanced Fibrosis

The FDA recently announced the approval of the semaglutide injection to treat metabolic-associated steatohepatitis (MASH) in adults with moderate to advanced fibrosis. Semaglutide was first approved in 2017 for obesity and to reduce cardiovascular events, and received breakthrough therapy designation, allowing it to be approved under the accelerated approval pathway.

An ongoing trial of 800 participants randomly assigned to semaglutide or placebo found that at week 72, 63% of participants receiving treatment had MASH resolution and no worsening of liver scarring, and 37% had improvement in liver scarring and no worsening of MASH compared with 34% and 22% of placebo participants respectively. The trial will continue to week 240, as researchers investigate if treatment decreases death, liver transplant, and other liver-related events.

The treatment’s side effects include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, flatulence, gastroenteritis, gastroesophageal reflux disease, nasopharyngitis, and hypoglycemia in patients with type 2 diabetes.

The FDA advises against those with a personal or family history of medullary thyroid cancer taking the medication, as well as those with multiple endocrine neoplasia, type 2 or with a known sensitivity to semaglutide.

Reference:
FDA approves treatment for serious liver disease known as ‘MASH’. FDA. Updated August 15, 2025. Accessed August 21, 2025. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-serious-liver-disease-known-mash