Health
Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP‑1 and amylin analogues for weight management
Today, Novo Nordisk announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (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 comorbid condition.1 CagriSema is a fixed-dose combination of a long-
About this update from Novo Nordisk A/s Class B
[{"type":"list","items":[{"val":[{"type":"text","content":"CagriSema 2.4 mg/2.4 mg is an investigational fixed-dose injectable medicine that combines the novel amylin analogue, cagrilintide, with semaglutide to target complementary obesity-related pathways1,2","length":200,"tagName":"p"}]},{"val":[{"type":"text","content":"In the REDEFINE 1 phase 3 trial, adults with obesity, or overweight with at least one obesity-related complication, taking CagriSema lost an average of 23% body weight when evaluating the treatment effect if all patients stayed on treatment*2","length":242,"tagName":"p"}]},{"val":[{"type":"text","content":"Novo Nordisk continues to build on its 100-year-plus legacy of science and innovation, with potential new treatments in obesity ","length":127,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":569,"olType":false},{"type":"text","content":"PLAINSBORO, N.J. and BAGSVÆRD, Denmark, Dec. 18, 2025 /PRNewswire/ -- Today, Novo Nordisk announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (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 comorbid condition.1 CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg, and the GLP-1 receptor agonist, semaglutide 2.4 mg.2 If approved, CagriSema would become the first injectable GLP-1 receptor agonist and amylin analogue combination treatment.","length":810,"tagName":"p"},{"type":"text","content":""The FDA submission of CagriSema marks an important milestone and signals a new era in weight management, reinforcing Novo Nordisk's long-standing commitment to serving people living with obesity through innovation and science," said Mike Doustdar, president and CEO of Novo Nordisk. "Building on the well-established profile of semaglutide and combining it with a novel mechanism of action, CagriSema has the potential to represent a meaningful step forward in the holistic treatment of obesity. With our leadership in metabolic disease, we are encouraged by the promise of this first-in-class combination to expand treatment o...