CDSCO Approves Wegovy for Fatty Liver Disease (MASH) in India
UPSC / SSC current affairs note
Why in news
The Central Drugs Standard Control Organization (CDSCO) has approved a new indication for Novo Nordisk's weight-loss drug Wegovy (semaglutide injection 2.4 mg) for treating noncirrhotic metabolic dysfunction associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis. This is the first GLP-1 RA approved globally and in India for MASH, addressing a condition affecting two in three Indians.
Background
MASH is a liver disease caused by excess fat build-up, leading to chronic inflammation and liver damage. It is often asymptomatic until advanced stages and can be life-threatening if unmanaged. Previously, treatment options for MASH were severely limited in India.
Key facts
CDSCO approved Wegovy (semaglutide injection 2.4 mg) for noncirrhotic MASH in adults with moderate to advanced liver fibrosis.
Wegovy is the first and only GLP-1 RA approved globally and in India for MASH.
The approval is for use alongside a reduced calorie diet and increased physical activity.
In the ESSENCE clinical trial, 63% of patients on Wegovy saw resolution of steatohepatitis, and 37% saw reduction in liver fibrosis.
Nearly 33% of patients achieved both resolution of steatohepatitis and improvement in liver fibrosis.
Liver benefits appear not solely explained by weight loss, suggesting broader impact on liver health.
Two in three Indians have fatty liver disease, according to estimates.
MASH increases risk of serious liver complications and heart-related disease.
Prelims pointers
- CDSCO: Central Drugs Standard Control Organization
- Wegovy: semaglutide injection 2.4 mg (GLP-1 RA)
- MASH: Metabolic dysfunction associated steatohepatitis (noncirrhotic)
- GLP-1 RA: Glucagon-like peptide-1 receptor agonist
- ESSENCE clinical trial: Phase 3 trial for Wegovy in MASH
Mains angles
- GS2 Health: Role of CDSCO in approving new drug indications and ensuring drug safety.
- GS3 Science & Technology: Advances in GLP-1 receptor agonists for metabolic diseases.
- GS2 Government Policies: Addressing rising burden of non-communicable diseases like fatty liver disease in India.