Novo Nordisk announced the submission of a New Drug Application (NDA) to the US 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.

"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. 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 options and address the evolving needs of patients," said Mike Doustdar, President and CEO, Novo Nordisk.

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. If approved, CagriSema would become the first injectable GLP-1 receptor agonist and amylin analogue combination treatment.

"This submission reflects the continued advancement of Novo Nordisk's obesity pipeline and our focus on translating scientific innovation into patient-relevant outcomes. If approved, CagriSema would provide patients and healthcare professionals with an additional treatment option supported by results from the REDEFINE clinical programme, including robust efficacy, high treatment completion rates, and a tolerability profile consistent with its underlying pharmacology. We believe these data underscore the potential of CagriSema to address unmet medical needs in obesity and support long-term disease management."

The FDA is expected to review the CagriSema application in 2026.