(Updates with the company's statement throughout.)
Novo Nordisk's (NVO) Indian unit said Friday that India's Central Drugs Standard Control Organization has approved Wegovy injection 2.4 mg for the treatment of noncirrhotic metabolic dysfunction associated steatohepatitis, or MASH, in adults with moderate to advanced liver fibrosis along with a reduced calorie diet and increased physical activity.
The approval was based on phase 3 trial data showing resolution of steatohepatitis in 63% of patients receiving Wegovy and reduction in liver fibrosis in 37% of patients, the company said.
MASH develops due to excess fat buildup in the liver, causing chronic inflammation and liver damage, according to the company.
Shares of Novo Nordisk were up 0.2% pre-bell Monday.