India has added a significant new indication to the label of semaglutide 2.4 mg. The Central Drugs Standard Control Organization has approved Novo Nordisk's Wegovy for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis, to be used alongside a reduced calorie diet and increased physical activity. With this decision, Wegovy becomes the first GLP-1 receptor agonist approved in both India and globally for this patient population.
The approval is supported by findings from the phase 3 ESSENCE trial , which enrolled 1,197 participants and randomized them in a 2 to 1 ratio to receive semaglutide 2.4 mg or placebo in addition to standard care. The study is designed to continue for 240 weeks, with the current approval based on interim efficacy data. According to the trial results, steatohepatitis resolved in…
