U.S. Approves First Treatment for Severe Form of Fatty Liver Disease
The U.S. health authorities approved the first-ever treatment for the severe form of human fatty liver disease on Thursday.
This condition affects millions of people across the United States, as reported by the French Press Agency.
Developed by Madrigal Pharmaceuticals, the treatment has been authorized for use in adults diagnosed with non-alcoholic steatohepatitis (NASH) who are suffering from liver fibrosis.
Non-alcoholic steatohepatitis is characterized by an abnormal accumulation of fat in the liver, leading to chronic inflammation of the organ. This can progressively lead to fibrosis, where healthy liver cells are replaced by scar tissue, which can further develop into cirrhosis or even liver cancer.
The disease is closely linked to obesity and represents a significant market for pharmaceutical companies.
The American Liver Foundation has expressed in a statement that the U.S. Food and Drug Administration's (FDA) decision brings hope to millions of Americans.
According to the Foundation, it is expected that by 2025, NASH will become the leading cause for liver transplants in the United States.
It is estimated that approximately 6 to 8 million Americans could benefit from this new treatment—a number that is expected to increase, the FDA projected.
Nickolay Nickolov of the FDA stated in a press release, "Until now, these patients had no medication that could directly address the liver damage."
The treatment is taken orally once daily, along with a healthy diet and regular exercise.
The authorization is based on a clinical trial involving around 900 individuals that showed significant benefit after 12 months for those who received the treatment, compared with others who were given a placebo.
Common side effects included diarrhea and nausea.
Bill Sibold, the CEO of Madrigal Pharmaceuticals, responded in a statement saying the authorization "marks the culmination of 15 years of research," describing it as a "historic moment" in the field.
The company announced that the treatment would be available to patients in the U.S. from April through specialized pharmacies.
Developed by Madrigal Pharmaceuticals, the treatment has been authorized for use in adults diagnosed with non-alcoholic steatohepatitis (NASH) who are suffering from liver fibrosis.
Non-alcoholic steatohepatitis is characterized by an abnormal accumulation of fat in the liver, leading to chronic inflammation of the organ. This can progressively lead to fibrosis, where healthy liver cells are replaced by scar tissue, which can further develop into cirrhosis or even liver cancer.
The disease is closely linked to obesity and represents a significant market for pharmaceutical companies.
The American Liver Foundation has expressed in a statement that the U.S. Food and Drug Administration's (FDA) decision brings hope to millions of Americans.
According to the Foundation, it is expected that by 2025, NASH will become the leading cause for liver transplants in the United States.
It is estimated that approximately 6 to 8 million Americans could benefit from this new treatment—a number that is expected to increase, the FDA projected.
Nickolay Nickolov of the FDA stated in a press release, "Until now, these patients had no medication that could directly address the liver damage."
The treatment is taken orally once daily, along with a healthy diet and regular exercise.
The authorization is based on a clinical trial involving around 900 individuals that showed significant benefit after 12 months for those who received the treatment, compared with others who were given a placebo.
Common side effects included diarrhea and nausea.
Bill Sibold, the CEO of Madrigal Pharmaceuticals, responded in a statement saying the authorization "marks the culmination of 15 years of research," describing it as a "historic moment" in the field.
The company announced that the treatment would be available to patients in the U.S. from April through specialized pharmacies.
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