India Approves Novo Nordisk's Wegovy for Fatty Liver Disease (MASH)
India's drug regulator, the Central Drugs Standard Control Organization (CDSCO), approved Novo Nordisk's weight-loss drug Wegovy (semaglutide injection 2.4 mg) for a new indication — fatty liver disease. It becomes the first and only GLP-1 receptor agonist approved both globally and in India for treating noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis, alongside diet and exercise. The approval is based on the Phase 3 ESSENCE trial, in which Wegovy showed resolution of steatohepatitis in 63% of patients and reduction in liver fibrosis in 37%.
Key Facts & Details
7 points- 1India's CDSCO approved Novo Nordisk's Wegovy (semaglutide 2.4 mg) for fatty liver disease.
- 2It is the first and only GLP-1 receptor agonist approved globally and in India for MASH.
- 3MASH is metabolic dysfunction-associated steatohepatitis, a fat-driven liver disease.
- 4Approval is based on the Phase 3 ESSENCE trial.
- 5The trial showed 63% resolution of steatohepatitis and 37% reduction in liver fibrosis.
Deep Dive
- +Wegovy (semaglutide) is a GLP-1 drug already known for weight management and diabetes.
- +The approval offers a new option addressing obesity and related liver and metabolic diseases.
Exam Focus
India's CDSCO approved which Novo Nordisk drug for fatty liver disease (MASH)?
Related Topics
Exam Relevance & Angle
Notable drug approvals are testable health/science GA items. Wegovy/semaglutide, the CDSCO approval and the MASH indication are precise hooks.
Target Exams
Background & Context
Semaglutide (sold as Wegovy/Ozempic) is a GLP-1 receptor agonist — a class of drugs that regulate blood sugar and appetite, now widely used for diabetes and obesity. MASH (metabolic dysfunction-associated steatohepatitis), formerly called NASH, is an advanced form of fatty-liver disease that causes inflammation and scarring (fibrosis) of the liver. A regulator's approval for a specific new use ('indication') is what lets a drug be marketed for that condition.
Test Yourself
1 / 2India's CDSCO approved which Novo Nordisk drug for fatty liver disease (MASH)?
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