Novo Nordisk Files NDA for Next-Generation Obesity Drug CagriSema

Core Insights - Novo Nordisk (NVO) has submitted a new drug application (NDA) to the FDA for CagriSema, a once-weekly injection aimed at reducing excess body weight in adults with obesity or overweight, with a review expected in 2026 [2][7] - CagriSema is a combination of cagrilintide and semaglutide, designed to suppress hunger and enhance fullness, potentially making it the first injectable therapy to combine a GLP-1 RA with an amylin analogue [3][4] - The NDA is supported by significant results from two phase III studies, REDEFINE 1 and REDEFINE 2, showing superior weight loss compared to placebo [4][9] Study Results - In the REDEFINE 1 study, CagriSema achieved an average weight loss of 22.7% compared to 2.3% with placebo, with 40.4% of patients losing 25% or more of their body weight [5][6] - The REDEFINE 2 study reported a mean weight loss of 15.7% with CagriSema versus 3.1% with placebo, with 89.7% of patients achieving at least 5% weight loss [9][10] - Overall, patients treated with CagriSema experienced a mean weight loss of 20.4% regardless of adherence, while the placebo group saw a 3% reduction [6][9] Market Context - Novo Nordisk's growth has been impacted by pricing pressures and competition from Eli Lilly's tirzepatide-based drugs, which have rapidly gained market share [11][12] - Eli Lilly's drugs generated $24.8 billion in sales in the first nine months of 2025, accounting for 54% of its total revenues [13] - To counteract competitive pressures, Novo Nordisk is diversifying its obesity portfolio and developing next-generation candidates, including oral formulations and partnerships for new treatments [14][15]