Central Drugs Standard Control Organization (CDSCO) Approves Wegovy for MASH Treatment

Key facts

• The Central Drugs Standard Control Organization (CDSCO) approved a new indication for Novo Nordisk's Wegovy (semaglutide injection 2.4 mg) for treating noncirrhotic metabolic dysfunction associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis.
• Wegovy is the first and only GLP-1 receptor agonist approved globally and in India for MASH, to be used alongside a reduced-calorie diet and increased physical activity.
• In the ESSENCE clinical trial, 63% of patients on Wegovy achieved resolution of steatohepatitis, 37% saw reduction in liver fibrosis, and 33% achieved both outcomes.
• According to estimates, two in three Indians have fatty liver disease, which can progress to life-threatening MASH if unmanaged.
• Wegovy is also indicated for chronic weight management in adults with a BMI of 30 kg/m² or greater (obesity) or 27 kg/m² or greater (overweight) with at least one weight-related comorbid condition.