India's Drug Panel Recommends Wegovy for Metabolic Liver Disease Treatment
New Delhi: In a significant development for the treatment of liver diseases linked to obesity and metabolic disorders, the Subject Expert Committee (SEC) on Endocrinology and Metabolism, functional under the CDSCO has recommended conditional approval for an additional indication of Semaglutide injection marketed under the brand name Wegovy by Novo Nordisk India Private Limited, for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (stages F2 to F3) in adults.
The recommendation was made during the SEC meeting held on April 23, 2026, after the company sought approval to expand the use of the drug beyond chronic weight management.
Noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), is a progressive liver disease characterized by liver fat buildup and inflammation without advanced scarring (cirrhosis). It is part of the broader MASLD spectrum driven by metabolic conditions like obesity, type 2 diabetes, and high cholesterol, requiring lifestyle changes and sometimes pharmacotherapy.
The firm presented a proposal for grant of approval of additional indication of Semaglutide Injection 0.25 mg / 0.5 mg / 1 mg / 1.7 mg / 2.4 mg [Brand Name: Wegovy] (r-DNA Origin).
The committee noted that the subject drug has been approved in India since 20.04.2022 for Semaglutide Injection 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg & 2.4 mg; Solution for injection in a prefilled pen for chronic weight management in adults.
After detailed deliberation, the committee recommended the grant of conditional approval for the proposed additional indications where the subject drug is indicated for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in adults, considering the significant therapeutic advancement over the current standard of care, in line with US accelerated approval for the proposed indication subject to the following conditions:
1. The Firm shall submit the complete Phase III CSR for the subject confirmatory ESSENCE Trial NN9931-4553 (Part-2).
2. Continued approval for proposed indication is subject to verification of safety and clinical benefit in a subject confirmatory trial NN9931-4553 (Part 2) titled as “A randomized, double-blind, placebo-controlled, parallel-group 240-week trial in patients with metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis to demonstrate clinical benefit on the composite endpoint of progression to cirrhosis, hepatic decompensation events, liver transplant, and mortality."
