FDA approves first drug for serious liver disease

The U.S. Food and Drug Administration (FDA) announced it has approved the first drug to treat a serious liver disease. Announced in the release Thursday.

The FDA has approved Rezdifla (Resmetilom) to treat adults with a common form of hepatitis called nonalcoholic steatohepatitis (NASH).

NASH, also known as metabolic dysfunction-associated steatohepatitis (MASH), occurs when the liver becomes inflamed due to excess fat cells. Over time, liver inflammation caused by NASH can lead to liver scarring and liver dysfunction.

Type 2 diabetes and high blood pressure are also health conditions often associated with NASH, according to the FDA.

“Until now, NASH patients with significant liver scarring have had no drugs that directly address their liver damage,” said Nikolai Nikolov, MD, acting director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research. . “Today’s approval of Rezdifla provides these patients with a treatment option in addition to diet and exercise for the first time.”

One estimate cited in the FDA release states that approximately 6 million to 8 million people in the United States have NASH with moderate to progressive liver scarring. Rezdifla is a partial activator of thyroid hormone receptors, and Rezdifla’s activation of this receptor in the liver “reduces liver fat accumulation,” according to the release.

Common side effects of Rezdifla include diarrhea and nausea. Additionally, warnings about this drug include drug-induced hepatotoxicity and gallbladder-related side effects.

Patients with decompensated cirrhosis should not use Rezdiffra, according to the release. On the other hand, if signs and symptoms of worsening liver function appear, patients should stop using the treatment.

According to the release, taking Rezdiffra with other drugs, especially cholesterol-lowering statins, can result in potentially serious drug interactions.