Emcure Pharmaceuticals has expanded the application of Poviztra, its GLP 1 medications drug, to treat a progressive liver disease with limited treatment options. The semaglutide will now be used for patients suffering from non-cirrhotic metabolic cirrodysfunction-associated steatohepatitis (MASH). This expansion follows the Central Drugs Standard Control Organisation’s (CDSCO) approval of Wegovy for the same indication.
Poviztra is Emcure’s co-marketed brand of innovator semaglutide (rDNA origin) and is now available for treating MASH in adults with moderate to advanced liver fibrosis (F2-F3). This marks the first approval of a GLP-1 molecule for MASH.
Poviztra is manufactured and imported from Novo Nordisk’s European facility and contains innovator rDNA-origin semaglutide. Emcure plans to promote the drug for MASH through its subsidiary, Zuventus Healthcare, which focuses on gastroenterology and hepatology.
MASH occurs due to excess fat accumulation in the liver, leading to chronic inflammation, fibrosis, and progressive liver damage. The disease is closely associated with obesity, type 2 diabetes, and other metabolic disorders, often remaining asymptomatic until it reaches advanced stages, making early diagnosis and intervention crucial.
Satish Mehta, CEO and Managing Director of Emcure Pharmaceuticals, stated that the approval for MASH represents an important milestone for patients living with this serious and often underdiagnosed liver disease.
In the global Phase III ESSENCE trial, semaglutide demonstrated a resolution of steatohepatitis in 63% of patients and an improvement in liver fibrosis in 37% of patients. One in three patients achieved both the resolution of steatohepatitis and improvement in liver fibrosis, highlighting semaglutide’s potential to address the underlying disease in addition to its established metabolic benefits.