India’s Fatty Liver Disease Burden: Wegovy Approval Targets MASH With F2–F3 Fibrosis

The Central Drugs Standard Control Organization (CDSCO) officially approves Novo Nordisk’s Wegovy for treating Metabolic Dysfunction-Associated Steatohepatitis (MASH). The approval covers adults with noncirrhotic MASH and moderate to advanced fibrosis (F2–F3), and uses evidence from the international ESSENCE clinical trial.

Wegovy (Semaglutide) Approval for MASH (F2–F3 Fibrosis):

Dimension	Key Details
Disease profile	MASH is highly progressive, causes chronic liver inflammation and scarring, and frequently shows no symptoms until reaching advanced stages.
Drug class and mechanism	Wegovy comprises a GLP-1 receptor agonist.
Administration route	Wegovy is administered as a once-weekly subcutaneous injection.
Patient eligibility	The approval applies to adults with noncirrhotic MASH and moderate to advanced fibrosis (F2–F3), combined with a low-calorie diet and exercise.
Claimed approval uniqueness	Wegovy is the first and only GLP-1 receptor agonist approved both globally and in India to treat a severe, progressive form of fatty liver disease.
Efficacy evidence base	The approval relies heavily on data from Part 1 of the international ESSENCE clinical trial.
Trial-reported therapeutic action	The ESSENCE clinical trial data provides that semaglutide directly targets liver fat, inflammation, and cellular scarring.
Trial outcome (resolution of steatohepatitis)	In the trial, 63% of patients experience a complete resolution of steatohepatitis (liver inflammation).
Trial outcome (fibrosis reduction)	In the trial, 37% of patients achieve a significant reduction in structural liver fibrosis without any worsening of their baseline liver inflammation.
Noted observation beyond weight loss	Researchers note that observed therapeutic liver benefits are not solely explained by body weight loss.
India burden estimate	Medical estimates indicate that approximately 2/3 individuals in India suffer from fatty liver disease.