The FDA has cleared the use of a unique treatment for a severe form of fatty liver disease that affects millions of people in the United States.
Treatment for hepatic steatosis, authorized in the USA – Photo Archive
The drug developed by Madrigal Pharmaceuticals has been authorized to be used by adults diagnosed with non-alcoholic steatohepatitis (NASH or, more recently, MASH), who suffer from liver fibrosis, according to Agerpres.
The disease consists of an abnormal accumulation of fats in the liver, which triggers chronic inflammation of this organ. Liver cells are gradually replaced by fibrosis, scar tissue that can degenerate into cirrhosis or even cancer. The condition is closely associated with obesity and until now there was no treatment. Thus, it represents an enormous market for pharmaceutical companies.
Specifically, hepatic steatosis represents the accumulation of excess fat around the liver, and the disease affects 30% of the Romanian population. Moreover, many patients are not aware of the presence of the condition.
The American Liver Foundation applauds the decision by the US Food and Drug Administration (FDA) and says the drug “brings hope to millions of Americans“, according to a statement.
The condition would become the leading cause of liver transplants in the United States by next year, the Foundation states.
Millions of people, targeted by the new treatment
An estimate by the US Food and Drug Administration (FDA) predicts that the new treatment could help between 6 and 8 million Americans, and the number would continue to rise. Until now, patients “they did not have a medicine that would act directly on their liver lesions“, said Nikolay Nikolov, FDA representative, quoted in a statement.
The medication is taken once a day by mouth and must be accompanied by a healthy diet and exercise. A clinical trial of about 900 people showed that after a period of 12 months, patients who received the treatment saw benefits compared to those who received a placebo. The most common side effects were diarrhea and nausea. This authorization “is the culmination of 15 years of research“said Bill Sibold, manager at Madrigal Pharmaceuticals.
“It's a historic moment” for this field, he also said, according to the quoted source.
From April, American patients will find the treatment in specialized pharmacies.
