Anti-obesity drug now indicated for adults with MASH and moderate to advanced liver fibrosis, without cirrhosis
Summary
Anvisa has approved the use of the drug Wegovy (semaglutide 2.4 mg) to treat MASH, a disease associated with obesity and overweight, thus expanding its indications and offering new therapeutic possibilities.
Anvisa approved the use of the drug (semaglutide 2.4 mg) for the treatment of fatty liver associated with inflammation. The condition, known as Metabolic dysfunction-associated steatohepatitis (MASH)affects adults with moderate to advanced hepatic fibrosis, without cirrhosis.
The decision broadens the indication of the drug, already used to treat obesity and overweight. From now on, he will be able to integrate the management of an illness considered silent and potentially serious.
What is MASH?
MASH is a condition directly associated with obesity and being overweight. Eight in ten overweight people live with the disease and, without proper diagnosis and treatment, it can progress to liver cirrhosis, making a liver transplant necessary. In addition, it increases the risk of cardiovascular diseases.
The disease is characterized by excessive accumulation of fat in the liver associated with an inflammatory process that damages liver cells and can lead to fibrosis. The disease is linked to metabolic changes, such as obesity, insulin resistance and other cardiometabolic factors. It is estimated that around 250 million people are currently living with MASH.
How Wegovy can help you with treatment
Data from a phase 3 clinical study, the ESSENCEshowed that 63% of patients treated with semaglutide 2.4 mg had resolution of hepatic inflammation, compared to 34.3% in the placebo group.
About 37% of patients showed an improvement in their fibrosis stage, compared to 22.4% of those who received the placebo. Additionally, about a third of patients treated with the drug simultaneously achieved reversal of inflammation and improvement in fibrosis.
The ESSENCE study is still ongoing. In the first phase, already completed, the improvement in liver histology was evaluated in 72 weeks. In the second phase, patients will be followed for 240 weeks, with the aim of verifying whether the use of semaglutide reduces serious liver-related clinical events, such as progression to cirrhosis.
“Today’s approval is an important step in the treatment of fatty liver disease in Brazil, a silent and serious disease directly linked to the obesity epidemic,” said Priscilla Mattar, endocrinologist and vice president of medical at New Nordisk in Brazil. According to her, until now, patients had few therapeutic alternatives capable of stopping the progression of the disease.
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