Emcure Pharmaceuticals Limited submitted a press release to the National Stock Exchange of India Limited and BSE Limited regarding the expansion of use for its co-marketed brand Poviztra®.
The Central Drugs Standard Control Organization (CDSCO) has approved Wegovy® for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (F2-F3). This approval enables Emcure and its subsidiaries to offer this new indication through Poviztra®, which contains innovator semaglutide (rDNA-origin).
Poviztra® is manufactured and imported from Novo Nordisk's European manufacturing facility. The approval addresses a significant unmet medical need for patients with MASH, a progressive liver disease with limited treatment options that develops from excess fat accumulation leading to chronic inflammation, fibrosis, and liver damage.
The approval is supported by results from the global Phase III ESSENCE trial, in which semaglutide demonstrated:
- Resolution of steatohepatitis in 63% of patients
- Improvement in liver fibrosis in 37% of patients
- One in three patients achieved both resolution of steatohepatitis and improvement in liver fibrosis
Satish Mehta, Chief Executive Officer & Managing Director of Emcure Pharmaceuticals Limited, stated that this approval marks an important milestone for patients and strengthens the company's commitment to bringing innovative therapies to India. The company will work to improve awareness, encourage earlier diagnosis, and expand access to treatment.
Poviztra® is already approved and marketed for:
- Chronic weight management in persons living with obesity and overweight with co-morbid conditions (e.g., Hypertension, Dyslipidemia, Type 2 Diabetes)
- Obese patients with established cardiovascular disease
- Management of adolescent obesity in pediatric patients above 12 years
The expansion to MASH treatment further strengthens the company's commitment to addressing complex metabolic diseases. Through its subsidiary Zuventus Healthcare's strong gastroenterology and hepatology portfolio, Emcure will help expand MASH awareness, diagnosis, and treatment.
Company Background
Emcure Pharmaceuticals Ltd. is a leading Indian pharma company headquartered in Pune, engaged in developing, manufacturing, and globally marketing pharmaceutical products. Established in 1981, the company is ranked as the 13th largest pharma company in India in terms of Domestic Sales for MAT March 2026 and is present in 70+ countries globally.