Previous
Dementia and Undiagnosed Liver Disease: What's the Connection?
Next
Vemlidy: FDA Expands Approval to Kids with Hepatitis B
Rezdiffra: First FDA-Approved Drug for Treating Fatty Liver Disease
The FDA has approved resmetitron (brand name Rezdiffra) for adult patients with moderate to advanced scarring of the liver due to fatty liver disease.
On February 19, 2024, we told you about resmetirom, a first-of-its-kind drug being developed to help treat nonalcohol steatohepatitis or NASH, a form of nonalcoholic fatty liver disease (NAFLD) now known as metabolic dysfunction-associated steatohepatitis or MASH. If you have fatty liver disease and have been waiting for a medication-based treatment, that day is here. On March 14, 2024, the U.S. Food and Drug Administration (FDA) approved resmetirom under the brand name Rezdiffra for adult patients with moderate to advanced scarring of the liver due to fatty liver disease. (1)
The FDA granted this drug accelerated approval, an option reserved for medications designed to treat serious conditions with “an unmet medical need.”
Rezdiffra a Game Changer in Fatty Liver Treatment
Until now, individuals with fatty liver disease had no drug available for treatment. Instead, the recommendations for managing this condition have generally involved losing weight, lowering cholesterol levels, and avoiding alcohol.
While this is still good advice, with diet and exercise a part of the treatment plan when using resmetirom, some patients may see additional benefits with this first-ever drug for MASH treatment. At least, they have in studies involving the drug.
Studies Support Rezdiffra Effectiveness
When developing Rezdiffra, Madrigal Pharmaceuticals (the drug’s manufacturer) completed 18 clinical trials using resmetirom to treat adult patients with liver fibrosis due to fatty liver disease. (2)
In several of these studies, resmetirom was found to either reduce NAFLD Activity Scores (NASs) while keeping fibrosis from progressing or, in some cases, decrease fibrosis with no progression of NAS after a full year of treatment.
A 54-month study, which is still ongoing, was evaluated to determine both the drug’s safety and effectiveness. It involves 888 subjects, all with liver inflammation and moderate to advanced liver scarring due to NASH.
After 12 months, between 24% and 36% of individuals receiving the drug had no worsening liver scarring or resolved their condition. Only 9% to 13% of the group receiving the placebo achieved the same.
Additionally, 23% to 28% of the group receiving different dosages of the drug (either 80 mg or 100 mg) had liver scarring improvement and no worsening of their condition compared to 13% to 15% of subjects receiving the sham drug.
How Resmetirom Works
Resmetirom is a thyroid hormone receptor (THR)-β selective agonist designed to treat fatty liver disease by targeting its underlying causes. Specifically, it helps reduce liver fat accumulation through thyroid hormone receptor activation. (2)
Thyroid hormones are important for fat or lipid metabolism. If this metabolism is disrupted, lipids can accumulate, leading to inflammation in the liver – also subsequently leading to fatty liver disease. (3)
Who May Not Be Suitable for Resmetirom Use
Like any drug, Rezdiffra is not suitable for all individuals with fatty liver disease. In the FDA’s approval statement, it indicates that it should not be used by individuals with decompensated cirrhosis. (1) It may also interfere with statin drugs, so healthcare providers may need to alter drug dosage or administration to avoid these effects.
Some people experience side effects when taking this drug. Diarrhea and nausea are the most common, though gallbladder issues and drug-induced liver toxicity can also occur.
If you wonder whether resmetirom might help you with your fatty liver disease, talk to your healthcare provider. They can help determine your treatment options based on your specific condition and its severity.
(1) U.S. Food and Drug Administration. (2024, March 14). FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease. Retrieved March 22, 2024, from https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-liver-scarring-due-fatty-liver-disease
(2) Madrigal Pharmaceuticals. (2023, September 13). Madrigal Pharmaceuticals Announces NDA Acceptance and Priority Review of the New Drug Application for Resmetirom for the Treatment of NASH with Liver Fibrosis. Retrieved March 22, 2024, from https://ir.madrigalpharma.com/news-releases/news-release-details/madrigal-pharmaceuticals-announces-nda-acceptance-and-priority
(3) Bikeyeva, V., Abdullah, A., Radivojevic, A., et al. (2022, August). Nonalcoholic Fatty Liver Disease and Hypothyroidism: What You Need to Know. Cureus. doi:10.7759/cureus.28052
About the Author
Christina M. DeBusk is a health writer and editor who specializes in natural wellness, disease prevention and treatment options. She is also a Certified Nutrition Specialist, Personal Trainer, and Transformation Specialist. You can find her articles in a variety of health-related publications, both online and in print.
