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Rachel V Thomas

Novo Nordisk's GLP-1 Drug Wegovy Approved for Fatty Liver Disease in India

India's drug regulator, the Central Drugs Standard Control Organization (CDSCO), has approved <span>Wegovy</span> (semaglutide injection 2.4 mg) for the treatment of adults with <span>fatty liver</span> disease, Novo Nordisk announced today.

According to the company, Wegovy is the first and only GLP-1 receptor agonist (GLP-1 RA) approved globally and in India for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis, alongside a reduced-calorie diet and increased physical activity.

"People with MASH face a higher risk of serious liver complications and heart-related disease. This approval is an important milestone, giving doctors and patients a new treatment option while also helping address obesity and related heart and metabolic diseases," said Vikrant Shrotriya, Managing Director, Novo Nordisk India.

The approval is based on findings from the ESSENCE clinical trial, which showed that:

<ul><li>63% of patients treated with Wegovy experienced resolution of steatohepatitis, an advanced form of fatty liver disease. </li><li>37% showed improvement in liver fibrosis. </li><li>33% achieved both resolution of steatohepatitis and improvement in liver fibrosis.</li></ul>Novo Nordisk said that the liver benefits were not solely explained by weight loss, suggesting semaglutide may have additional effects on liver health.

Semaglutide injection (Wegovy) is indicated, alongside a reduced-calorie diet and increased physical activity, for: 

<ul><li>Chronic weight management in adults with a BMI of 30 kg/m² or higher, or 27 kg/m² or higher with at least one weight-related condition such as hypertension, type 2 diabetes, or dyslipidaemia. </li><li>Chronic weight management in adolescents aged 12 years and older with obesity and a body weight above 60 kg. </li><li>Reducing the risk of major adverse cardiovascular events (cardiovascular death, non-fatal heart attack, or non-fatal stroke) in adults with established cardiovascular disease who are overweight or have obesity. </li><li>Treatment of noncirrhotic MASH with moderate to advanced liver fibrosis (F2-F3) in adults. </li></ul><h2>What Is MASH?</h2>

Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease caused by excess fat accumulation in the liver, leading to chronic inflammation and liver damage.

According to Novo Nordisk, two in three Indians have fatty liver disease. The condition is often called a "silent disease" because many people do not develop symptoms until liver damage has become advanced. If left untreated, MASH can progress to severe liver complications. 

"MASH is becoming more common in India as lifestyles change. In many people, early MASH has no obvious symptoms, so the condition may not be diagnosed until liver damage is more advanced," said Dr. Dharmesh Kapoor, Senior Consultant Hepatologist, Hyderabad. 

He stressed the importance of early screening, particularly for people with obesity, type 2 diabetes, or other metabolic conditions. 

"Wegovy has demonstrated benefits in reducing liver inflammation and fibrosis while also supporting weight management and blood sugar control, both of which are linked to MASH progression," Dr. Kapoor added.

Novo Nordisk said innovator semaglutide is backed by more than 50 clinical trials, 49 million patient-years of exposure, and extensive real-world evidence. 

The medicine, manufactured using recombinant DNA (rDNA) technology, has been approved in 75 countries, including by the Drugs Controller General of India (DCGI), the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

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India's drug regulator, the Central Drugs Standard Control Organization (CDSCO), has approved Wegovy (semaglutide injection 2.4 mg) for the treatment of adults with fatty liver disease, Novo Nordisk announced today. According to the company, Wegovy is the first and only GLP-1 receptor agonist (GLP-1 RA) approved globally and in India for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis, alongside a reduced-calorie diet and increased physical activity."People with MASH face a higher risk of serious liver complications and heart-related disease. This approval is an important milestone, giving doctors and patients a new treatment option while also helping address obesity and related heart and metabolic diseases," said Vikrant Shrotriya, Managing Director, Novo Nordisk India.Clinical Trial FindingsThe approval is based on findings from the ESSENCE clinical trial, which showed that:63% of patients treated with Wegovy experienced resolution of steatohepatitis, an advanced form of fatty liver disease. 37% showed improvement in liver fibrosis. 33% achieved both resolution of steatohepatitis and improvement in liver fibrosis.Novo Nordisk said that the liver benefits were not solely explained by weight loss, suggesting semaglutide may have additional effects on liver health.Who Should Take Wegovy? Semaglutide injection (Wegovy) is indicated, alongside a reduced-calorie diet and increased physical activity, for: Chronic weight management in adults with a BMI of 30 kg/m² or higher, or 27 kg/m² or higher with at least one weight-related condition such as hypertension, type 2 diabetes, or dyslipidaemia. Chronic weight management in adolescents aged 12 years and older with obesity and a body weight above 60 kg. Reducing the risk of major adverse cardiovascular events (cardiovascular death, non-fatal heart attack, or non-fatal stroke) in adults with established cardiovascular disease who are overweight or have obesity. Treatment of noncirrhotic MASH with moderate to advanced liver fibrosis (F2-F3) in adults. What Is MASH? Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease caused by excess fat accumulation in the liver, leading to chronic inflammation and liver damage. According to Novo Nordisk, two in three Indians have fatty liver disease. The condition is often called a "silent disease" because many people do not develop symptoms until liver damage has become advanced. If left untreated, MASH can progress to severe liver complications. "MASH is becoming more common in India as lifestyles change. In many people, early MASH has no obvious symptoms, so the condition may not be diagnosed until liver damage is more advanced," said Dr. Dharmesh Kapoor, Senior Consultant Hepatologist, Hyderabad. He stressed the importance of early screening, particularly for people with obesity, type 2 diabetes, or other metabolic conditions. "Wegovy has demonstrated benefits in reducing liver inflammation and fibrosis while also supporting weight management and blood sugar control, both of which are linked to MASH progression," Dr. Kapoor added. Novo Nordisk said innovator semaglutide is backed by more than 50 clinical trials, 49 million patient-years of exposure, and extensive real-world evidence. The medicine, manufactured using recombinant DNA (rDNA) technology, has been approved in 75 countries, including by the Drugs Controller General of India (DCGI), the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

novo nordisk's glp-1 drug wegovy approved for fatty liver disease in india

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