Prelims: Current events of national and international importance | Health
Why in News?
The Central Drugs Standard Control Organization (CDSCO), officially approved Novo Nordisk’s Wegovy for treating Metabolic Dysfunction-Associated Steatohepatitis (MASH).
MASH is highly progressive, causing chronic liver inflammation and scarring, but frequently shows no symptoms until reaching advanced stages.
Wegovy
- It is primarily known as a blockbuster chronic weight management drug.
- It is now the first and only GLP-1 receptor agonist approved both globally and in India to treat a severe, progressive form of fatty liver disease.
- The approval targets a critical public health crisis in India, where medical estimates indicate that approximately 2/3 individuals suffer from fatty liver disease.
- Mechanism - GLP-1 Receptor Agonist
- Route - Once-weekly subcutaneous injection.
- Approved Mash Patient Criteria
- Adults with Noncirrhotic MASH
- Moderate to Advanced Fibrosis (F2-F3)
- Combined with a low-calorie diet & ex.
- Efficacy Data - The approval relies heavily on data from Part 1 of the international ESSENCE clinical trial, which proved that semaglutide directly targets liver fat, inflammation, and cellular scarring.
- 63% of patients experienced a complete resolution of steatohepatitis (liver inflammation).
- 37% of patients achieved a significant reduction in structural liver fibrosis without any worsening of their baseline liver inflammation.
- Beyond Weight Loss – Crucially, researchers noted that the observed therapeutic liver benefits were not solely explained by body weight loss, indicating a distinct protective pathway on liver tissues.
Reference
The Indian Express | Wegovy