Premium

US FDA approves blockbuster weight loss drug for severe fatty liver disease: Here’s what you need to know

Altogether 63 per cent receiving semaglutide reported improvement and no worsening of liver scarring

For most people diagnosed to have fat accumulation in the liver, doctors suggest diet and exercise as a means of reducing body fat as well as the fat deposition in the abdomen and various organs, including the liver.

The US Food and Drug Administration (FDA) has approved the popular weight-loss drug semaglutide for the treatment of the liver condition called metabolic associated steatohepatitis (MASH) — previously referred to as non-alcoholic steatohepatitis. It is a more severe form of non-alcoholic fatty liver disease, where the fat deposition on the liver leads to inflammation and liver cell damage.

The medicine was first approved in 2017 for the treatment of diabetes. It has since been approved for the treatment of obesity and associated cardiovascular diseases.

What is MASH?

The condition starts off as non-alcoholic, or as it is now known metabolic-associated, fatty liver disease. This fat build-up, over time, leads to inflammation and scarring of the liver, reducing the efficiency of the organ. Importantly, it can further progress to severe scarring called cirrhosis and then liver cancer.

The challenge is that most people remain unaware of the condition in the initial stages. It is only when there has been significant damage to the organ that people experience symptoms such as abdominal pain, fatigue and weakness, loss of appetite, weight loss, and jaundice (yellowing of the eyes and skin caused by bilirubin buildup when the liver does not function properly).

Why is this significant?

With obesity on the rise, there has been an increase in the incidence of MASH. For most people diagnosed to have fat accumulation in the liver, doctors suggest diet and exercise as a means of reducing body fat as well as the fat deposition in the abdomen and various organs, including the liver.

ALSO READ | Doctor shares case of person ‘who never touched alcohol’ yet was diagnosed with fatty liver: ‘He came for just a routine check-up’

Yet, it was only last year that the very first treatment for the condition was approved by the US FDA. Resmetirom, along with diet and exercise, was shown to resolve MASH and prevent worsening of the liver scarring. It works by activating a receptor that controls processes such as lipid metabolism, thereby reducing fat in the liver and its inflammation.

Semaglutide, on the other hand, works by addressing underlying risk factors such as obesity, abdominal deposition of fat, diabetes, and insulin resistance.

Story continues below this ad

What is the data supporting the approval of semaglutide for MASH?

A phase III trial of 800 people — randomly prescribed semaglutide (534 participants) or placebo (266 participants) — showed that 63 per cent receiving the drug saw resolution of MASH and no worsening of the liver scarring as compared to 34 per cent receiving placebo. The interim trial data also shows that 37 per cent of the participants on semaglutide showed improvement in liver scarring and no worsening of MASH as compared to 22 per cent receiving placebo at 72 weeks after initiating treatment.

“The trial will continue for a total of 240 weeks to determine whether inflammation and scarring improvements seen after 72 weeks translate into decreases in death, liver transplant and other liver-related events,” the FDA said in a statement.

What is the status of MASH in India?

It is estimated that anywhere between nine per cent and 32 per cent of the population in India is living with metabolic associated fatty liver disease — the beginning stage of MASH. A study published earlier this year showed more than 84 per cent of the IT sector employees in Hyderabad had increased liver fat accumulation, indicating MAFLD. The study — based on data from 345 IT employees — found that 76.5 per cent had high levels of bad cholesterol, 70.7 per cent were obese, and 20.9 per cent had higher than normal fasting blood glucose levels.

Anonna Dutt

Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. She reported on the government’s management of the Covid-19 pandemic and closely followed the vaccination programme. Her stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports. Dutt also takes a keen interest in the country’s space programme and has written on key missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan. She was among the first batch of eleven media fellows with RBM Partnership to End Malaria. She was also selected to participate in the short-term programme on early childhood reporting at Columbia University’s Dart Centre. Dutt has a Bachelor’s Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. She started her reporting career with the Hindustan Times. When not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. ... Read More