First drug for severe form of fatty liver disease approved: All about it – Times of India

Fatty liver disease is one of the most neglected health issues with severe complications. Fatty liver disease, also known as hepatic steatosis, is a condition characterized by an accumulation of fat in the liver cells. This buildup of fat can lead to liver inflammation and damage over time. It is commonly associated with obesity, high cholesterol, type 2 diabetes, and excessive alcohol consumption.Non-alcoholic fatty liver disease (NAFLD) is prevalent among individuals who do not consume excessive alcohol. If left untreated, fatty liver disease can progress to more severe conditions such as non-alcoholic steatohepatitis (NASH), liver cirrhosis, or even liver failure.
The first medication for non-alcoholic steatohepatitis (NASH), a severe form of fatty liver disease was approved by the US Food and Drug Administration (FDA) on Thursday. NASH affects approximately 6-8 million people in the United States, and is often associated with other health problems such as high blood pressure, type 2 diabetes, obesity and high blood fat levels.

What is NASH?

Non-alcoholic steatohepatitis (NASH) is a more severe form of non-alcoholic fatty liver disease (NAFLD), characterized by liver inflammation and damage alongside fat accumulation in the liver. NASH involves inflammation and can progress to liver fibrosis, cirrhosis, and potentially liver cancer. While some individuals with NAFLD may never develop NASH, others may progress to this advanced stage.

Symptoms of NASH can be nonspecific and may include fatigue, weakness, weight loss, and abdominal discomfort. Diagnosis often involves imaging tests and liver biopsies to assess the extent of liver damage. Treatment for NASH focuses on lifestyle modifications such as weight loss, dietary changes, exercise, and managing underlying conditions like diabetes and high cholesterol. In more advanced cases, medications and sometimes liver transplantation may be necessary.

All about the new medication

Rezdiffra, also known by its molecule name resmetirom, is an oral drug that targets the underlying causes of NASH. The drug is set to be available to US patients in April.
Madrigal Pharmaceuticals’ Rezdiffra was shown to improve liver scarring in a clinical trial involving hundreds of people with non-alcoholic steatohepatitis (NASH), the worst form of the condition caused by a buildup of fat in the liver. “Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage,” said the FDA’s Nikolay Nikolov. “Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise.”
Common side effects included diarrhea and nausea.
(Agency: AFP)