With drug body's clearance, Wegovy is first GLP-1 for adults with fatty liver, Pg10

Key Highlights:

• The Central Drugs Standard Control Organisation (CDSCO) has approved Wegovy (semaglutide 2.4 mg) for treating Metabolic Dysfunction-Associated Steatohepatitis (MASH) in adults.
• This marks the first approval of an injectable GLP-1 therapy in India specifically for MASH, beyond its use for obesity.
• The approval followed positive results from the ESSENCE trial, showing significant resolution of steatohepatitis and reduction in liver fibrosis.
• MASH, a severe form of fatty liver disease, affects a significant portion of the Indian population.

Detailed Insights:

• Wegovy, containing semaglutide, mimics a natural gut hormone to regulate blood sugar, reduce appetite, and slow digestion.
• The drug directly targets and reduces liver fat, inflammation, and scarring, addressing the core pathology of MASH.
• The ESSENCE trial demonstrated that Wegovy resolved steatohepatitis in 63% of patients and reduced liver fibrosis in 37% of patients.
• MASH is a progressive liver disease resulting from excess fat buildup, leading to chronic inflammation and potential liver damage.
• The treatment is indicated for adults with moderate to advanced liver fibrosis (stages F2 to F3), alongside a reduced calorie diet and increased physical activity.
• The approval is crucial given the rising burden of MASH in India and its association with higher risks of serious liver complications and heart-related diseases.

Key Concepts Involved:

• Central Drugs Standard Control Organisation (CDSCO): India's principal regulatory body for pharmaceuticals and medical devices.
• Metabolic Dysfunction-Associated Steatohepatitis (MASH): A severe, progressive form of fatty liver disease characterized by inflammation and liver cell damage.
• GLP-1 (Glucagon-like peptide-1): A natural gut hormone that plays a role in blood sugar regulation, appetite control, and digestion.
• Semaglutide: The active pharmaceutical ingredient in Wegovy, a GLP-1 receptor agonist.
• ESSENCE trial: A clinical trial that evaluated the efficacy and safety of semaglutide in treating MASH.