First drug for serious liver disease receives FDA approval

The U.S. Food and Drug Administration (FDA) made an announcement on Thursday, stating that they have approved the first ever drug for the treatment of serious liver disease.

The FDA has given its approval for the use of Rezdiffra (resmetirom) in treating nonalcoholic steatohepatitis (NASH), a prevalent liver inflammation condition among adults.

NASH, also referred to as metabolic dysfunction-associated steatohepatitis or MASH, occurs when the liver experiences inflammation due to an excessive buildup of fatty cells. Over time, this inflammation can result in the development of liver scarring and impaired liver function.

According to the FDA, NASH is often associated with other health conditions such as type 2 diabetes and high blood pressure.

Dr. Nikolay Nikolov, who is the acting director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research, stated that patients with NASH and significant liver scarring previously lacked a medication that could specifically target their liver damage. He further added that the approval of Rezdiffra now offers a treatment option for these patients, alongside the recommended dietary and exercise measures.

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According to the FDA’s release, it is estimated that around 6-8 million individuals in the United States suffer from NASH with moderate to advanced liver scarring. The release states that Rezdiffra, a partial activator of the thyroid hormone receptor, can help reduce liver fat accumulation when activated in the liver.

Rezdiffra may cause common side effects like diarrhea and nausea. It is important to note that the drug carries warnings for potential drug-induced liver toxicity and gallbladder-related side effects.

According to the release, individuals suffering from decompensated cirrhosis are advised against using Rezdiffra. Additionally, if patients experience any indications or symptoms of deteriorating liver function, they should discontinue the treatment.

Mixing Rezdiffra with other medications, especially statins used to lower cholesterol, can lead to potentially significant drug interactions, according to the release.

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