On 17 July 2026 the Central Drugs Standard Control Organization (CDSCO) approved Novo Nordisk’s Wegovy (semaglutide 2.4 mg) for treatment of noncirrhotic metabolic dysfunction‑associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis, to be used with a reduced‑calorie diet and increased physical activity.
Metabolic Dysfunction‑Associated Steatohepatitis (MASH)
- Definition: Progressive steatohepatitis linked to metabolic dysfunction; part of the MASLD spectrum.
- Risk factors: Obesity, type 2 diabetes mellitus, dyslipidaemia.
- Fibrosis staging: F0–F4; CDSCO approval targets adults with fibrosis stages F2–F3 (noncirrhotic).
Wegovy (semaglutide)
- Drug class: Glucagon‑like peptide‑1 (GLP‑1) receptor agonist; formulation: 2.4 mg subcutaneous injection.
- Labelled use: First GLP‑1 authorised for noncirrhotic MASH in India and globally for this indication.
- Domestic marketing: Emcure Pharmaceuticals distributes semaglutide as Poviztra in India.
Clinical evidence and regulatory timeline
- ESSENCE trial: 63% achieved histological resolution of steatohepatitis; 37% showed fibrosis improvement.
- Regulatory steps: CDSCO Subject Expert Committee recommended approval on 23 Apr 2026; CDSCO approval on 17 Jul 2026.
- Earlier approvals: US MASH approval Aug 2025; Canada conditional approval Dec 2025; Indian weight‑management approval 20 Apr 2022.
Market access and pricing
- Price change: Monthly price of Poviztra reduced to ₹3,999 from ₹8,790 effective 3 Apr 2026.
- Use conditions: Indication specified as adjunct to calorie restriction and increased physical activity.
IASPOINT Booster Facts
- Regulator: CDSCO operates under the Ministry of Health and Family Welfare; Subject Expert Committees advise on indications.
- Histological endpoint: Resolution defined as loss of hepatocyte ballooning and lobular inflammation without fibrosis worsening.
- Fibrosis assessment: Gold standard: liver biopsy; non‑invasive tools: transient elastography (FibroScan), FIB‑4 score.
- MASLD nomenclature: MASLD replaces NAFLD/NASH in recent clinical consensus for metabolic‑related steatotic liver disease.