CDSCO Approves Novo Nordisk’s Wegovy for Fatty Liver Disease in India
GS2Polity · Governance · IR· Health policy & public health· Prelims·
Why in news
The CDSCO approved Novo Nordisk’s Wegovy (semaglutide) as the first injectable GLP-1 therapy in India specifically for treating Metabolic Dysfunction-Associated Steatohepatitis (MASH).
Background
The Central Drugs Standard Control Organisation (CDSCO) approved Wegovy (semaglutide 2.4 mg) for adults with moderate to advanced liver fibrosis. The approval is based on the ESSENCE trial, which showed a 63% resolution of steatohepatitis and a 37% reduction in fibrosis.
Facts for Prelims
- BodyCDSCO: The national regulatory body for cosmetics, pharmaceuticals, and medical devices in India.
- S&TSemaglutide: A GLP-1 (glucagon-like peptide-1) receptor agonist used to treat obesity and metabolic disorders.
- FactWegovy dosage: Approved at 2.4 mg via injection for MASH treatment.
- FactESSENCE Trial: Clinical trial demonstrating 63% steatohepatitis resolution and 37% fibrosis reduction.
For Mains
Q. Discuss the significance of GLP-1 receptor agonists in managing metabolic disorders and the role of regulatory bodies in ensuring the safety of novel pharmaceutical therapies in India.
Dimensions to cover in your answer
- Regulatory oversight: Balancing rapid approval of novel biotech drugs with rigorous safety monitoring for chronic metabolic conditions
- Accessibility gap: High cost of proprietary injectable therapies vs. the need for affordable healthcare for metabolic diseases
Keywords: Metabolic Dysfunction-Associated Steato… · GLP-1 Receptor Agonists · Regulatory Approval · Pharmaceutical Innovation · Non-communicable Diseases
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