Anvisa Approves Wegovy for MASH With Moderate-to-Advanced Fibrosis in Adults

Overview

• Brazil’s decision covers adults without cirrhosis who have metabolic dysfunction–associated steatohepatitis with moderate-to-advanced fibrosis.
• The ESSENCE phase 3 trial reported 63% MASH resolution with semaglutide versus 34.3% with placebo, 37% fibrosis improvement versus 22.4%, and 33% achieving both outcomes at 72 weeks.
• Roughly 1,200 participants were randomized 2:1 to semaglutide or placebo for up to 240 weeks, with the ongoing second phase assessing liver-related clinical events and a readout expected in 2029.
• The authorization was published in Brazil’s Diário Oficial da União on December 15, formalizing the new indication.
• Wegovy is the 2.4 mg semaglutide GLP-1 therapy already approved in Brazil for weight management, as officials highlight the heavy global burden of fatty liver disease.