Emcure’s Poviztra gets CDSCO nod for fatty liver treatment

Emcure Pharmaceuticals Ltd on Monday said its co-marketed brand of the innovator semaglutide, Poviztra, will now be available for the treatment of fatty liver.

This followed the Central Drugs Standard Control Organisation's (CDSCO) approval of 'Wegovy' for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis, the company said in a statement.

Poviztra is manufactured and imported from Novo Nordisk's European manufacturing facility and contains innovator rDNA-origin semaglutide, it added.

Last year, in November, Novo Nordisk India and Emcure Pharma had announced a partnership to launch weight loss medicine Poviztra, semaglutide injection 2.4 mg, as a second brand of Wegovy in India.

The approval enables Emcure and its subsidiaries to offer the new indication through Poviztra, expanding access to innovator semaglutide for patients living with a progressive liver disease that has long faced limited treatment options, the company said.

Commenting on the development, Emcure Pharmaceuticals Ltd CEO & MD Satish Mehta said, “The approval for MASH marks an important milestone for patients living with a serious and often underdiagnosed liver disease.” Last week, Novo Nordisk India announced the receipt of approval from CDSCO for the indication of its Wegovy injection in the treatment of fatty liver disease in India.

It made Wegovy the first and only GLP-1 RA to be approved both globally and in India for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis along with a reduced calorie diet and increased physical activity, it added.

MASH is a liver disease that develops due to excess fat buildup in the liver, causing chronic inflammation and liver damage.

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