Emcure Pharmaceuticals gets CDSCO nod for MASH treatment in adults with liver fibrosis

Pharmaceutical company Emcure Pharmaceuticals Ltd on Monday (July 20) announced that its co-marketed brand Poviztra can now be used for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (F2-F3), following approval from the Central Drugs Standard Control Organisation (CDSCO).

Poviztra is a co-marketed brand of innovator semaglutide (rDNA origin) and is manufactured and imported from Novo Nordisk's European manufacturing facility.

The CDSCO approval follows approval of Wegovy for the indication and makes the innovator molecule from Novo Nordisk the first and only GLP-1 receptor agonist approved in India for the treatment of MASH, according to Emcure Pharmaceuticals.

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

Through its subsidiary Zuventus Healthcare, Emcure said it will support MASH awareness, diagnosis and treatment through its gastroenterology and hepatology portfolio.

MASH develops when excess fat accumulation in the liver leads to chronic inflammation, fibrosis and progressive liver damage. Closely linked with obesity, type 2 diabetes and other metabolic disorders, the disease is often asymptomatic until advanced stages, making timely diagnosis and intervention critical.

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The approval is supported by results from the global Phase III ESSENCE trial, in which semaglutide demonstrated resolution of steatohepatitis in 63% of patients and improvement in liver fibrosis in 37% of patients.

One in three patients achieved both resolution of steatohepatitis and improvement in liver fibrosis1, highlighting semaglutide's potential to address the underlying disease in addition to its established metabolic benefits.

Satish Mehta, Chief Executive Officer and Managing Director, Emcure Pharmaceuticals Ltd, said, "The approval for MASH marks an important milestone for patients living with a serious and often underdiagnosed liver disease.

We are pleased to make this important new indication available through Poviztra®, further strengthening our commitment to bringing globally validated, innovative therapies to patients in India.

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We look forward to working closely with healthcare professionals to improve awareness, encourage earlier diagnosis and expand access to evidence-based treatment for people living with MASH."

Poviztra contains innovator semaglutide (rDNA-origin) that has already established its role in chronic weight management in persons living with obesity and those who are overweight with co-morbid conditions(example Hypertension, Dyslipedemia, Type 2 Diabetes,etc).

Shares of Emcure Pharmaceuticals Ltd ended at ₹1,857.80, down by ₹73.95, or 4.15%, on the BSE.