Novo Nordisk A/S: Wegovy® approved in the US for the treatment of MASH

Core Viewpoint - Novo Nordisk has received FDA approval for Wegovy (semaglutide 2.4 mg) to treat noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis, marking it as the first GLP-1 treatment approved for this condition [1][4]. Group 1: FDA Approval and Clinical Data - The FDA's accelerated approval is based on part 1 of the ESSENCE trial, which showed Wegovy's significant improvement in liver fibrosis without worsening steatohepatitis compared to placebo [2]. - At week 72 of the ESSENCE trial, 36.8% of Wegovy-treated participants showed improvement in liver fibrosis, while 62.9% achieved resolution of steatohepatitis, compared to 22.4% and 34.3% in the placebo group, respectively [3]. Group 2: MASH Overview - MASH is a serious, progressive liver disease affecting over 250 million people globally, with the number of individuals in advanced stages expected to double by 2030 [5]. - Approximately one in three individuals with overweight or obesity also suffer from MASH, with around 22 million people in the US estimated to be affected [4][5]. Group 3: ESSENCE Trial Details - The ESSENCE trial is a phase 3 study involving 1,200 participants, randomized to receive semaglutide 2.4 mg or placebo, aimed at demonstrating improvements in liver histology at 72 weeks [6]. - Part 2 of the trial will assess the reduction of liver-related clinical events over 240 weeks, with results expected in 2029 [7]. Group 4: Wegovy's Background - Wegovy was initially approved in 2021 for weight management and has since expanded its indications to include children and to reduce cardiovascular risks in adults with heart disease [8].