全球第二款！司美格鲁肽获FDA批准治疗MASH

Core Viewpoint - Novo Nordisk's weight loss drug Wegovy has received accelerated approval from the FDA for the treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH), solidifying the company's position in the metabolic disease sector [6][8]. Summary by Sections FDA Approval and Market Position - Wegovy is the first GLP-1 class drug approved for MASH, a serious liver disease affecting approximately 5% of U.S. adults according to the American Liver Foundation [6]. - Novo Nordisk is now one of only two FDA-approved therapies for MASH, with the other being Madrigal Pharmaceuticals' Rezdiffra, approved in 2024 [6]. Clinical Study Results - In a study, 62.9% of patients treated with 2.4 mg semaglutide experienced relief from steatohepatitis without worsening fibrosis, compared to 34.3% in the placebo group, showing a significant difference of 28.7% (P<0.001) [7]. - For the second primary endpoint, 36.8% of the semaglutide group showed improvement in fibrosis without worsening fatty liver, versus 22.4% in the placebo group, with a difference of 14.4% (P<0.001) [7]. - The study's first part highlights the potential of semaglutide to delay the progression of cirrhosis and end-stage liver disease [7]. Treatment Availability and Future Plans - Wegovy is now available in the U.S. for adults with MASH and moderate to severe fibrosis, requiring a balanced diet and exercise [8]. - Novo Nordisk is working with insurers to expand coverage but has not disclosed specific pricing [8]. - The company has applied for approval in Europe and Japan based on the study's first part results, with complete data from the second part expected in 2029 [8]. Competitive Landscape - Eli Lilly is also developing treatments for MASH, with its active ingredient tirzepatide showing that up to 74% of patients achieved resolution of MASH without worsening fibrosis in a mid-stage study [8].