The U.S. Food and Drug Administration (FDA) has approved the first drug to treat serious liver disease, the agency announced in a release Thursday.
The FDA has allowed the use of Rezdiffra (resmetirom) to treat adults dealing with a common type of liver inflammation called nonalcoholic steatohepatitis, or NASH.
NASH, also known as metabolic dysfunction-associated steatohepatitis, or MASH, occurs when the liver becomes inflamed due to an excess of fatty cells. Liver inflammation from NASH, over time, can lead to liver scarring and liver dysfunction.
The FDA states that NASH is often linked to type 2 diabetes and high blood pressure.
Nikolay Nikolov, M.D., acting director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research, noted that before Rezdiffra, patients with NASH and notable liver scarring did not have a medication that could directly address their liver damage. Rezdiffra now offers a treatment option for these patients alongside diet and exercise.
The FDA’s release mentions an estimated 6-8 million people in the U.S. with NASH and moderate to advanced liver scarring. Rezdiffra works by partially activating the thyroid hormone receptor in the liver, which helps reduce liver fat accumulation.
Common side effects of Rezdiffra include diarrhea and nausea. However, users should be aware of potential drug-induced liver toxicity and gallbladder-related side effects.
Individuals with decompensated cirrhosis should avoid using Rezdiffra, and users should discontinue treatment if they experience worsening liver function.
Using Rezdiffra with other drugs, especially statins for lowering cholesterol, could lead to significant drug interactions, according to the release.
