India approves Wegovy as first GLP-1 drug for fatty liver disease MASH
The Central Drugs Standard Control Organisation (CDSCO) has approved Novo Nordisk's Wegovy (semaglutide 2.4 mg) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), a serious form of fatty liver disease. This marks the first time an injectable GLP-1 therapy has been authorised for this indication in India, beyond its existing approval for obesity.
MASH, formerly known as non-alcoholic steatohepatitis (NASH), involves chronic inflammation and liver damage, often progressing to fibrosis or cirrhosis. The drug is indicated for adults with moderate to advanced liver fibrosis (stages F2 to F3), to be used alongside a reduced-calorie diet and increased physical activity.
The approval is based on the ESSENCE trial, which showed that after 72 weeks, 63% of patients receiving Wegovy experienced resolution of steatohepatitis without worsening of fibrosis, compared to 34% on placebo. Additionally, 37% of patients showed an improvement in liver fibrosis without worsening of steatohepatitis, versus 22% on placebo. Notably, the liver benefits appeared independent of weight loss, suggesting a direct effect on liver fat, inflammation, and scarring.
Wegovy is a GLP-1 receptor agonist, mimicking a natural gut hormone that regulates blood sugar, reduces appetite, and slows digestion. The approved dose for MASH is 2.4 mg administered once weekly via subcutaneous injection. Common side effects include nausea, vomiting, and diarrhoea, though serious risks like pancreatitis and gallbladder disease require monitoring.
This regulatory decision offers a new treatment option for a condition that affects an estimated 5–10% of Indian adults, with limited pharmacological therapies previously available. Experts caution, however, that the drug is not a cure and that lifestyle modifications remain central to management. Long-term data on cardiovascular and liver-related outcomes are still being gathered.
