(Washington) American health authorities authorized on Thursday a first treatment against a serious form of “human fatty liver disease”, which affects millions of people in the United States.
This treatment, developed by Madrigal Pharmaceuticals, is authorized for adults with non-alcoholic steatohepatitis (NASH) and suffering from liver fibrosis.
NASH consists of an abnormal accumulation of fats in the liver, triggering chronic inflammation of this organ. Its cells are gradually replaced by fibrosis, scar tissue which can itself degenerate into cirrhosis or even cancer.
It is a disease closely linked to obesity, and represents a huge market for pharmaceutical groups.
The decision of the American Medicines Agency (FDA), “brings hope to millions of Americans”, reacted the American Liver Foundation in a press release.
According to her, NASH is expected to become the leading cause of liver transplants in the United States by 2025.
About 6 to 8 million Americans are potentially affected by this new treatment, a number that is expected to continue to increase, according to an estimate cited by the FDA.
Until now, these patients “did not have a drug that could directly act on the damage to their liver,” Nikolay Nikolov, an official at the FDA, said in a statement.
The treatment is taken orally once a day, in addition to a good diet and exercise.
The authorization was based on a clinical trial carried out on around 900 people, which showed after 12 months a benefit for those who received the treatment, 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,” responded Bill Sibold, manager at Madrigal Pharmaceuticals, in a press release. “This is a historic moment” for this area, he added.
The treatment will be available to patients in the United States starting in April, through specialty pharmacies, the company said.
Nonalcoholic steatohepatitis is now also called MASH.