NEW Delhi: Emcure Pharmaceuticals has announced that its brand Poviztra, containing innovator semaglutide (rDNA origin) has eceived nod from Central Drugs Standard Control Organisation (CDSCO) to be sold in the market. It will now be available for treating adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (F2-F3).
The approval makes semaglutide the first and only GLP-1 receptor agonist approved in India for treating MASH, a progressive liver disease that is emerging as a major public health concern because of the country’s growing burden of obesity, diabetes and metabolic syndrome, said the company in its statement here.
MASH, previously known as non-alcoholic steatohepatitis (NASH), develops when excess fat accumulates in the liver, triggering chronic inflammation and scarring (fibrosis). Over time, the condition can progress to cirrhosis, liver failure and liver cancer if left untreated.
The disease often remains undetected because patients may not experience symptoms during the early stages. Many are diagnosed only after significant liver damage has occurred during routine health examinations or investigations for other illnesses.
Doctors said India is witnessing a rapid rise in metabolic liver disease, driven by increasing rates of obesity, sedentary lifestyles and Type 2 diabetes. While fatty liver is common, only a proportion of patients progress to MASH, where persistent inflammation causes irreversible liver injury.
Until now, treatment has largely focused on controlling weight, blood sugar and cholesterol, alongside dietary changes and exercise, with no approved medicine specifically targeting the disease process.
Experts said the approval is significant because semaglutide addresses not only the metabolic abnormalities associated with obesity but also the underlying inflammation and fibrosis responsible for progressive liver damage.
The approval is based on findings from the global Phase III ESSENCE clinical trial.
According to trial results, 63 per cent of patients experienced resolution of steatohepatitis, indicating that liver inflammation subsided without worsening fibrosis. In addition, 37 per cent showed improvement in liver fibrosis, while nearly one-third achieved both resolution of liver inflammation and reversal of fibrosis.
These findings suggest that the medicine may slow or even partially reverse disease progression in carefully selected patients before irreversible cirrhosis develops.
For patients diagnosed with moderate-to-advanced fibrosis, this could potentially delay or prevent serious complications, including liver failure and the need for liver transplantation.
The company said, Poviztra already contains innovator semaglutide imported from Novo Nordisk’s European manufacturing facilities and is currently approved in India for chronic weight management in people with obesity or overweight accompanied by medical conditions such as hypertension, dyslipidaemia and Type 2 diabetes.
The medicine is also approved for obese patients with established cardiovascular disease and adolescents aged 12 years and above with obesity.
The addition of the MASH indication further expands its role in treating metabolic diseases that frequently coexist in the same patient.
Experts caution, however, that semaglutide is not a substitute for lifestyle modification. Weight reduction, healthy diet, regular physical activity and effective control of diabetes and other metabolic disorders will continue to remain central to MASH management.
For further query, kindly contact indiahealthbuddy@gmail.com
