Novo Nordisk says India’s Central Drugs Standard Control Organisation (CDSCO) has approved a new indication for Wegovy (semaglutide injection 2.4 mg) to treat metabolic dysfunction–associated steatohepatitis (MASH) in adults. The approval covers noncirrhotic MASH in people with moderate to advanced liver fibrosis, alongside lifestyle measures including a reduced-calorie diet and increased physical activity. Both outlets report that the approval makes Wegovy the first and only GLP-1 receptor agonist (GLP-1 RA) with this indication in India, and that it aligns with Wegovy’s global approvals for the same condition. MASH is described as a liver disease linked to excess fat accumulation in the liver, which can trigger chronic inflammation and progressive liver damage. Novo Nordisk India also says the burden of MASH is rising in the country, while treatment options remain limited. The drug is positioned for use as part of a broader management approach that includes diet and exercise. The companies’ statements do not provide additional details on pricing, availability, or treatment protocols beyond the approved indication.
Wegovy approved in India for treatment of metabolic dysfunction–associated steatohepatitis
Novo Nordisk says India’s Central Drugs Standard Control Organisation (CDSCO) has approved a new indication for Wegovy (semaglutide injection 2.4 mg) to treat metabolic dysfunction–associated steatohe...
- CDSCO approves a new indication for Novo Nordisk’s Wegovy (semaglutide injection 2.4 mg) in India.
- The approval is for noncirrhotic MASH (metabolic dysfunction–associated steatohepatitis) in adults with moderate to advanced liver fibrosis.
- Wegovy is reported to be the first and only GLP-1 receptor agonist approved in India for this MASH indication.
- The indication is to be used with a reduced-calorie diet and increased physical activity.
- MASH is linked to excess fat in the liver, causing inflammation and liver damage over time.
Novo Nordisk India on Friday said it has received approval from the Central Drugs Standard Control Organisation for indication of its Wegovy injection for the treatment of fatty liver disease in India. The Central Drugs Standard Control Organisation (CDSCO) has approved a new indication for Wegovy (semaglutide injection 2.4 mg), Novo Nordisk India said in a statement. It makes Wegovy the first and only GLP-1 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, it added. MASH is a liver disease that develops due to excess fat buildup in the liver, causing chronic inflammation and liver damage. Novo Nordisk India MD Vikrant Shrotriya 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 .
4 hours agoThe product is the first and only GLP-1 for adults with fatty liver disease in India, Novo Nordisk says
4 hours ago
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