Yesterday (Thursday), US health authorities approved the first treatment for the severe form of human fatty liver disease, which affects millions of people in the United States, according to Agence France-Presse.
This treatment, developed by Madrigal Pharmaceuticals, is now permitted for adults with non-alcoholic steatohepatitis (NASH) who suffer from cirrhosis.
Non-alcoholic steatohepatitis is manifested by abnormal accumulation of fat in the liver; Which leads to chronic inflammation in this organ. Its cells are gradually replaced by fibrosis, which is scar tissue that can turn into cirrhosis or even cancer.
This disease is closely linked to obesity, and represents a huge market for pharmaceutical groups.
The American Liver Foundation said in a statement that the decision of the US Food and Drug Administration (FDA) brings hope to millions of Americans.
According to the foundation, non-alcoholic steatohepatitis is expected to become the leading cause of liver transplants in the United States by 2025.
About 6 to 8 million Americans are likely to be affected by this new treatment, a number that is expected to continue to increase, according to FDA estimates.
FDA official Nikolai Nikolov said in a statement that these patients “until now, have not had a medication that can directly affect the damage to the liver.”
The treatment is taken orally once daily, in addition to following a proper diet and exercising.
The license was based on a clinical trial conducted on about 900 people, which after 12 months showed a benefit for those who received the treatment, compared to others who received a placebo.
The most common side effects were diarrhea and nausea.
The director of Madrigal Pharmaceuticals, Bill Siebold, responded in a statement that this license “culminates 15 years of research,” adding: “It is a historic moment” in this field.
The company said that the treatment will be available to patients in the United States starting in April through specialized pharmacies.
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2024-03-17 03:53:29
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