
Reuters
Novo Nordisk said on Friday that India’s drug regulator has approved its blockbuster obesity drug Wegovy for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), a serious and progressive form of fatty liver disease.The Central Drugs Standard Control Organisation (CDSCO) has approved Wegovy’s 2.4 mg semaglutide injection for the treatment of MASH, the Danish drugmaker said. The approval follows a recommendation by the CDSCO’s Subject Expert Committee (SEC) on Endocrinology and Metabolism, which had cleared the drug for adults with noncirrhotic MASH with moderate to advanced liver fibrosis, at stages F2 to F3, during a meeting held on April 23, 2026.Also read: Fatty liver new treatment found: Study discovers a medicine that reverses severe fatty liver by just repairing the gutMASH, formerly known as nonalcoholic steatohepatitis (NASH), is caused by a buildup of fat in the liver that can lead to inflammation and liver damage. The condition is part of a broader spectrum of fatty liver disease and can progress to more severe complications, including cirrhosis and liver failure, if left untreated.Novo Nordisk said about two in three people in India have fatty liver disease, underscoring the country’s large potential patient population. The company described it as a silent disease, noting that people often do not experience symptoms until it has progressed to an advanced stage.Wegovy contains the active ingredient semaglutide and was first approved in India on April 20, 2022, for chronic weight management, before Friday’s expanded approval for the liver condition. The drug is already approved in multiple markets for weight management, and had previously secured MASH approvals abroad, including in the US in August 2025, where it became the first and only GLP-1 receptor agonist approved to treat adults with MASH with moderate to advanced liver scarring, excluding cirrhosis, and in Canada, where it received conditional marketing authorization as the first and only treatment for adults with non-cirrhotic MASH.Also read: Fatty liver disease’s early sign can show up in legs: Doctor issues warning and how to identifyThe US approval was based on Part 1 of the ESSENCE trial, which showed a statistically significant improvement in liver fibrosis with no worsening of steatohepatitis, along with resolution of steatohepatitis without worsening of fibrosis, compared with placebo.Novo has been vying for a share of India’s fast-growing obesity-drug market against Eli Lilly’s Mounjaro and lower-cost generic semaglutide products launched by local drugmakers such as Dr Reddy’s and Sun Pharma. The company sold about 76,000 units of Wegovy in India in the first six months of 2026, according to data from market researcher Pharmarack.Add ![]()
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