速递｜68周减重22.7%，司美格鲁肽联合减肥药递交FDA冲刺

Core Viewpoint - Novo Nordisk has submitted a new drug application for CagriSema to the U.S. FDA, marking a significant advancement in the weight loss medication sector, aimed at obese or overweight adults with at least one weight-related comorbidity [6] Group 1: Product Overview - CagriSema combines a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist with cagrilintide, both at a dosage of 2.4 mg, administered via weekly subcutaneous injection [6] - If approved, CagriSema will be the first weight loss therapy to integrate GLP-1 receptor agonists and glucagon-like peptide analogs in a single injection regimen, representing a significant expansion of current treatment options [6] Group 2: Clinical Research Findings - The core evidence for the application is based on two pivotal Phase III clinical studies, REDEFINE 1 and REDEFINE 2 [6] - In REDEFINE 1, CagriSema demonstrated a significant weight loss advantage, with an average weight reduction of 20.4% in the treatment group compared to 3.0% in the control group at week 68, a statistically significant difference [6] - In a scenario where all participants continued treatment, the average weight loss for CagriSema increased to 22.7% at week 68, while the control group saw only a 2.3% reduction [8] - Approximately 92% of patients in the treatment group achieved at least a 5% weight loss, compared to about 30% in the control group, highlighting the potential of the dual mechanism approach in enhancing weight loss and stability [8] Group 3: Market Implications - In a competitive landscape for weight loss medications, Novo Nordisk aims to leverage technological innovation to differentiate itself from competitors [8] - The potential approval of CagriSema could reshape clinical choices in weight loss treatment and significantly impact the market structure of existing GLP-1 medications [8]