India approves Novo Nordisk’s weight loss drug Wegovy for fatty liver disease
India's Central Drugs Standard Control Organization (CDSCO) has approved Novo Nordisk's weight loss drug Wegovy (semaglutide injection 2.4 mg) for a new indication: noncirrhotic metabolic dysfunction associated steatohepatitis (MASH), a form of fatty liver disease. This marks the first global and Indian approval of a GLP-1 RA for MASH in adults with moderate to advanced liver fibrosis, to be used alongside a reduced calorie diet and increased physical activity. The approval is based on the phase 3 ESSENCE trial, which showed that Wegovy resolved steatohepatitis in 63% of patients and reduced liver fibrosis in 37% of patients. Novo Nordisk India's managing director Vikrant Shrotriya called the approval an important milestone for addressing MASH, obesity, and related metabolic diseases.
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