Wire flash
HealthIndia approves Novo Nordisk's Wegovy for fatty liver disease MASH
Editorial responsibility
- No named human review is recorded for this page.
- Source reporting is collected, normalized, translated or condensed automatically when needed.
- Automatically published source-backed update
India's Central Drugs Standard Control Organization (CDSCO) has approved Novo Nordisk's weight loss drug Wegovy (semaglutide injection 2.4 mg) for a new indication: noncirrhotic metabolic dysfunction associated steatohepatitis (MASH), a form of fatty liver disease. This marks the first global and Indian approval of a GLP-1 RA for MASH in adults with moderate to advanced liver fibrosis, to be used alongside a reduced calorie diet and increased physical activity. The approval is based on the phase 3 ESSENCE trial, which showed that Wegovy resolved steatohepatitis in 63% of patients and reduced liver fibrosis in 37% of patients. Novo Nordisk India's managing director Vikrant Shrotriya called the approval an important milestone for addressing MASH, obesity, and related metabolic diseases.
Source report
Source: HYDERABAD – The Hindu Bureau
The Central Drugs Standard Control Organization (CDSCO) has approved Danish pharmaceutical major Novo Nordisk’s weight loss drug Wegovy (semaglutide injection 2.4 mg) for a new indication — fatty liver disease.
Wegovy has become the first and only GLP-1 RA to be approved both globally and in India for the treatment of noncirrhotic metabolic dysfunction associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis, when used alongside a reduced calorie diet and increased physical activity. MASH is a liver disease that develops due to excess fat buildup in the liver, causing chronic inflammation and liver damage, Novo Nordisk India said on Friday.
“This approval is an important milestone, giving doctors and patients a new option for people at risk of MASH while also helping to address obesity and related heart and metabolic diseases,” said Vikrant Shrotriya, Managing Director of Novo Nordisk India.
The approval is based on the ESSENCE phase 3 trial, in which Wegovy demonstrated:
- Resolution of steatohepatitis in 63% of patients
- Reduction in liver fibrosis in 37% of patients
The two-part trial randomized 1,197 participants in a 2:1 ratio to receive either semaglutide 2.4 mg or a placebo, on top of standard care, for 240 weeks, the company stated in a release.
Source
The Hindu: Latest News today from India and the World, Breaking news, Top Headlines and Trending News Videos.Regional
Part of this Story
India approves Novo Nordisk’s weight loss drug Wegovy for fatty liver disease