Emcure Pharmaceuticals Limited has expanded the use of its co-marketed brand Poviztra® following the approval of innovator semaglutide (rDNA origin) by the Central Drugs Standard Control Organization (CDSCO) for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH). The approval allows Poviztra® to be used for adults with moderate to advanced liver fibrosis (F2-F3), offering a new treatment option for patients affected by the progressive liver disease.
With this approval, innovator semaglutide from Novo Nordisk becomes the first and only GLP-1 receptor agonist approved in India for the treatment of MASH. The decision enables Emcure and its subsidiaries to expand patient access to the therapy and strengthen treatment options for a disease that has had limited medical interventions.
MASH is a serious liver disorder caused by excess fat accumulation in the liver, which leads to inflammation, fibrosis and gradual liver damage. The disease is closely associated with obesity, type 2 diabetes and other metabolic conditions. Since MASH often develops without noticeable symptoms, many patients remain undiagnosed until the disease reaches an advanced stage, making early detection and timely treatment increasingly important.
The approval is based on findings from the global Phase III ESSENCE clinical trial, where semaglutide demonstrated encouraging outcomes in patients with MASH. The study showed that 63 per cent of patients experienced resolution of steatohepatitis, while 37 per cent recorded improvement in liver fibrosis. In addition, one in every three patients achieved both resolution of steatohepatitis and improvement in liver fibrosis, highlighting the therapy’s ability to address the underlying disease while delivering established metabolic benefits.
Commenting on the development, Satish Mehta, Chief Executive Officer and Managing Director, Emcure Pharmaceuticals Limited, said the approval marks an important step for patients living with a serious yet frequently underdiagnosed liver disease. He said the company is pleased to introduce the new indication through Poviztra® and remains committed to bringing globally validated therapies to patients across India. He added that Emcure will continue working with healthcare professionals to improve awareness, encourage earlier diagnosis and expand access to evidence-based treatment for MASH.
Poviztra® already plays an important role in chronic weight management for people living with obesity and overweight individuals with related health conditions such as hypertension, dyslipidaemia and type 2 diabetes. The medicine is also approved for obese patients with established cardiovascular disease and for the treatment of obesity in adolescents aged 12 years and above.
The addition of the MASH indication further strengthens Emcure’s portfolio in metabolic care and reflects its continued focus on addressing complex diseases through research-driven therapies. The company believes the expanded indication will help physicians deliver better long-term outcomes for patients while improving access to advanced treatment options.
Headquartered in Pune, Emcure Pharmaceuticals is one of India’s leading pharmaceutical companies engaged in the research, development, manufacturing and marketing of a wide range of medicines. Established in 1981, the company is ranked among the country’s leading pharmaceutical firms by domestic sales and has a presence in more than 70 countries, including markets across Europe and Canada.
