Novo Nordisk(US:NVO) Mei Ri Jing Ji Xin Wen·2025-08-16 06:40Core Insights - Novo Nordisk's semaglutide (Wegovy) has received FDA approval for a supplemental new drug application (sNDA) to treat metabolic dysfunction-associated steatotic liver disease (MASH) in patients with moderate to advanced liver fibrosis (F2 or F3) [1][2] - The approval is based on positive results from the Phase III ESSENCE study, which demonstrated significant improvements in liver fibrosis and steatohepatitis without worsening conditions [2][3] - The MASH indication represents a significant opportunity for GLP-1 drugs, with a large unmet clinical need and a projected market capacity exceeding $10 billion by 2025, growing at a compound annual growth rate (CAGR) of 20.19% from 2016 to 2025 [4][5] Group 1: Drug Approval and Study Results - The FDA approval was based on the ESSENCE study, a 240-week randomized, double-blind, placebo-controlled trial involving 1,200 patients [2] - Part 1 of the study showed that 36.8% of patients treated with 2.4 mg semaglutide experienced significant liver fibrosis improvement compared to 22.4% in the placebo group [3] - The study also indicated that 62.9% of the semaglutide group had resolution of steatohepatitis without worsening fibrosis, compared to 34.3% in the placebo group [3] Group 2: Market Context and Competitive Landscape - MASH is a critical area of focus for GLP-1 drugs, with significant unmet clinical needs and strong correlations with metabolic diseases [4][5] - Novo Nordisk's semaglutide is the first and currently the only GLP-1 drug approved for MASH, enhancing its competitive position in the market [3][5] - In the first half of the year, Novo Nordisk reported sales of 112.756 billion Danish Krone for semaglutide, leading the market significantly ahead of competitors [5]