|
Emcure Pharmaceuticals on Monday said its obesity drug brand Poviztra will now be available for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) after the Central Drugs Standard Control Organization (CDSCO) approved the new indication, making semaglutide the first and only GLP-1 receptor agonist approved in India for the progressive liver disease.
The company said the approval allows Poviztra, its co-marketed brand of innovator semaglutide (rDNA origin), to be used for treating non-cirrhotic MASH in adults with moderate to advanced liver fibrosis (F2-F3). The announcement was made through a company press release submitted to stock exchanges. "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," Emcure Pharmaceuticals Chief Executive Officer and Managing Director Satish Mehta said. "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," he added. According to the company, MASH develops when excess fat accumulates in the liver, leading to chronic inflammation, fibrosis and progressive liver damage. It is closely associated with obesity, type 2 diabetes and other metabolic disorders, and often remains undiagnosed until the disease reaches an advanced stage. Emcure said the approval is supported by results from the global Phase III ESSENCE trial, in which semaglutide achieved resolution of steatohepatitis in 63 per cent of patients and improvement in liver fibrosis in 37 per cent of patients. The company said one in three patients experienced both resolution of steatohepatitis and improvement in liver fibrosis, highlighting the drug's potential to address the underlying disease in addition to its metabolic benefits. The company said Poviztra is manufactured and imported from Novo Nordisk's European manufacturing facility and already has approved indications for chronic weight management, obesity-related cardiovascular disease and adolescent obesity. The addition of the MASH indication, it said, expands its portfolio for treating metabolic diseases. (ANI)
|
