CDSCO approves Wegovy® as first and only GLP-1 for adults living with fatty liver disease in India

Novo Nordisk India has announced that the Central Drugs Standard Control Organization (CDSCO) has approved a new indication for Wegovy^® (semaglutide injection 2.4 mg), making it the first and only GLP-1 receptor agonists (RA) to be approved both globally and in India for the treatment of noncirrhotic metabolic dysfunction associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis along with a reduced calorie diet and increased physical activity. 

MASH is a liver disease that develops due to excess fat buildup in the liver, causing chronic inflammation and liver damage. Two in three Indians have fatty liver disease. It is a silent disease and people often do not have symptoms until the disease has progressed to an advanced stage.

Vikrant Shrotriya, Managing Director, Novo Nordisk India, said, “The burden of MASH continues to rise in India, but treatment options are still severely limited. People with MASH face a higher risk of serious liver complications and heart-related disease. That is why we need treatment options that can address these connected health risks. This approval is an important milestone, giving doctors and patients a new option for people at risk of MASH while also helping to address obesity and related heart and metabolic diseases.”

Novo Nordisk’s innovator semaglutide, the active pharmaceutical ingredient in Wegovy^®, is backed by 50+ clinical trials, 49 million patient years of exposure, and extensive real-world evidence. Innovator semaglutide is manufactured using rDNA technology and is approved by regulatory authorities across 75 countries including the Drugs Controller General of India (DCGI), European Medicines Agency (EMA), United States Food & Drug Administration (US FDA) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan.