On Thursday, US health authorities approved the first treatment for a serious form of “human fatty liver disease” that affects millions of people in the United States, AFP reported.

Fatty liver disease has been diagnosed even in people without risk factorsPhoto: © Prostockstudio | Dreamstime.com

The treatment, developed by Madrigal Pharmaceuticals, is approved for adults with nonalcoholic steatohepatitis (NASH) who suffer from liver fibrosis.

NASH is an abnormal accumulation of fat in the liver, which causes chronic inflammation of this organ. Its cells are gradually replaced by fibrosis, scar tissue, which, in turn, can turn into cirrhosis or even cancer.

This disease is closely related to obesity and represents a huge market for pharmaceutical groups.

The decision by the US Food and Drug Administration (FDA) “gives hope to millions of Americans,” the American Liver Foundation said in a press release.

NASH is expected to become the leading cause of liver transplants in the United States by 2025, according to the foundation.

About 6 to 8 million Americans are eligible for this new treatment, and that number is expected to rise, according to an estimate provided by the FDA.

Until now, these patients “have not received drugs that directly affect liver damage,” FDA chief Nikolai Nikolov said in a press release.

Treatment is given orally once a day, supplemented with a healthy diet and exercise.

The approval was based on clinical trials involving approximately 900 people that showed benefits at 12 months for those who received the treatment compared to those who received a placebo.

The most common side effects were diarrhea and nausea.

The approval “is the culmination of 15 years of research,” Bill Siebold, chairman of Madrigal Pharmaceuticals, said in a news release. “This is a historic moment” for the field, he added.

The treatment will be available to patients in the United States starting in April at specialty pharmacies, the company said.

Photo: Prostockstudio | Dreamstime.com