India Approves Novo Nordisk’s Wegovy for Fatty Liver Disease (MASH): Key Features, Benefits & Significance

Why in News ?

India's drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has approved Novo Nordisk's Wegovy (Semaglutide 2.4 mg injection) for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH), a serious form of fatty liver disease.

What is MASH (Metabolic Dysfunction-Associated Steatohepatitis) ?

• MASH is a serious and progressive form of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
• It occurs due to excess fat accumulation in the liver, accompanied by inflammation and liver cell damage.
• If left untreated, it may progress to :
  • Liver fibrosis
  • Cirrhosis
  • Liver failure
  • Hepatocellular carcinoma (Liver cancer)

Risk Factors of MASH

• Obesity : Excess body weight increases the accumulation of fat in the liver, making obesity one of the major risk factors for MASH.
• Type-2 Diabetes : People with Type-2 diabetes are at a significantly higher risk of developing MASH due to insulin resistance and abnormal fat metabolism.
• Metabolic Syndrome : Conditions such as high blood sugar, high blood pressure, abnormal cholesterol levels, and excess abdominal fat collectively increase the risk of MASH.
• High Cholesterol : Elevated levels of cholesterol and triglycerides promote fat deposition in the liver, contributing to the development and progression of MASH.
• Sedentary Lifestyle : Lack of regular physical activity increases the likelihood of obesity and metabolic disorders, thereby raising the risk of developing MASH.

Symptoms of MASH

• MASH is often referred to as a "silent disease" because many people do not experience noticeable symptoms until the disease has progressed to an advanced stage and significant liver damage has occurred.
• The possible symptoms include :
  • Fatigue: Patients may experience persistent tiredness and a lack of energy.
  • Weakness: Generalized weakness and reduced physical stamina are common.
  • Pain in the Upper Right Abdomen: Some individuals may feel discomfort or pain in the upper right side of the abdomen, where the liver is located.
  • Unexplained Weight Loss : In advanced stages of the disease, patients may experience unintended weight loss due to progressive liver damage.

What is Wegovy ?

How Does Wegovy Work ?

• Semaglutide acts as a GLP-1 (Glucagon-Like Peptide-1) receptor agonist.
• It helps by :
  • Reducing appetite
  • Increasing satiety (feeling of fullness)
  • Promoting weight loss
  • Improving insulin sensitivity
  • Reducing liver fat accumulation
  • Decreasing liver inflammation

Why is this Approval Important ?

• Rising prevalence of obesity and diabetes in India.
• Increasing burden of fatty liver disease.
• MASH has limited approved treatment options.
• Early treatment can prevent severe liver complications.

About Novo Nordisk

• Danish multinational pharmaceutical company.
• Headquarters: Bagsværd, Denmark
• Known for :
• Diabetes medicines
• Obesity drugs
  • GLP-1 therapies

About the Central Drugs Standard Control Organisation (CDSCO)

• The Central Drugs Standard Control Organisation (CDSCO) is India's National Drug Regulatory Authority, responsible for regulating pharmaceuticals and medical devices to ensure that they are safe, effective, and of high quality.

Functions of CDSCO

• Approves New Drugs and Vaccines : CDSCO grants approval for the manufacture, import, and marketing of new drugs and vaccines after evaluating their safety, efficacy, and quality.
• Regulates Clinical Trials : It oversees and regulates clinical trials conducted in India to ensure ethical standards and participant safety.
• Ensures Quality, Safety, and Efficacy : CDSCO monitors the quality, safety, and effectiveness of medicines, medical devices, and cosmetics available in the country.
• Coordinates with State Drug Authorities : It works in coordination with State Drug Control Organisations to ensure uniform enforcement of the Drugs and Cosmetics Act, 1940.

Administrative Ministry

• The CDSCO functions under the Ministry of Health and Family Welfare, Government of India.

Head of CDSCO

• The organisation is headed by the Drugs Controller General of India (DCGI), who is responsible for approving new drugs, regulating clinical trials, and enforcing drug standards across the country.