Posted by Michael Wonder on 18 Dec 2025
Novo Nordisk files for FDA approval of CagriSema, the first onceweekly combination of GLP‑1 and amylin analogues for weight management
18 December 2025 - – Today, Novo Nordisk announced the submission of a new drug application to the US FDA for once weekly CagriSema (cagrilintide 2.4 mg and semaglutide 2.4 mg) injection, to be used with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight in the presence of at least one weight-related co-morbid condition.
The new drug application is based on results from REDEFINE 1, a 68 week, Phase 3, randomised, double-blind, placebo-and active-controlled trial that evaluated the efficacy and safety of once weekly, CagriSema compared to semaglutide 2.4 mg alone, cagrilintide 2.4 mg alone, or placebo, all as an adjunct to lifestyle intervention in 3,417 adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with one or more obesity-related complications and without diabetes, and REDEFINE 2, a double-blind, randomised, placebo-controlled, 68 week, Phase 3 trial that evaluated the efficacy and safety of once weekly CagriSema versus placebo, as an adjunct to lifestyle intervention in 1,206 adults with type 2 diabetes and either obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²).
